COMMISSION STAFF WORKING DOCUMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals
Date: 2023-12-07
Institutions: Directorate-General for Environment, European Commission
Subjects: chemical product, chemicals legislation, database, disclosure of information, environmental protection, exchange of information, information system, marketing standard, product safety, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.12.2023  SWD(2023) 855 final  COMMISSION STAFF WORKING DOCUMENT    Accompanying the document Proposal for a  REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals      {COM(2023) 779 final}  
 
 
Table of contents 

1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ......................... 5 

1.1.  Political context ..................................................................................... 5 
1.2.  Legal context ......................................................................................... 8 
1.3.  Scope of the document ........................................................................ 10 

2.  PROBLEM DEFINITION ............................................................................ 20 

2.1.  What is/are the problems? ................................................................... 20 
2.2.  What are the problem drivers? ............................................................ 25 

3.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ......................................... 26 

3.1.  General objectives ............................................................................... 26 
3.2.  Specific objectives ............................................................................... 26 

4.  WHAT ARE THE AVAILABLE OPTIONS? .............................................. 28 

4.1.  What is the baseline from which options are assessed? ...................... 28 
4.2.  Description of how problems can be addressed .................................. 45 

5.  WHAT ARE THE IMPACTS OF THE IDENTIFIED OPTIONS? ............. 72 

5.1.  Addressing the problem that information is difficult to find, share or re-
use and some information flows are suboptimal ................................. 72 
5.2.  Standard data formats .......................................................................... 76 
5.3.  Transparency and use of chemicals data contained in the common data 
platform ............................................................................................... 76 
5.4.  Addressing  the  problem  that  there  is  no  default  generation  or 
submission of certain types of chemicals data .................................... 78 
5.5.  Addressing the problem of an insufficient uptake of academic data ... 79 
5.6.  Addressing  the  problem  that  duty  holders  may  not  report  all  study 
results ................................................................................................... 81 
5.7.  Addressing  the  problem  that  a  mechanism  is  lacking  for  the 
identification of emerging chemical risks ........................................... 88 

6.  COMPARISON OF OPTIONS AND IDENTIFICATION OF PREFERRED 
OPTION ........................................................................................................ 89 

6.1.  Addressing  the  problem  that  chemicals  data  is  scattered  and  some 
information flows are suboptimal ........................................................ 89 
6.2.  Addressing the problem that chemicals data is not always interoperable
 ............................................................................................................. 89 
6.3.  Addressing the problem that chemicals data is not always accessible 89 
6.4.  Addressing  the  problem  that  there  is  no  default  generation  or 
submission of certain types of chemicals data .................................... 90 
6.5.  Addressing the problem of an insufficient uptake of academic data ... 91 
6.6.  Addressing  the  problem  that  duty  holders  may  not  report  all  study 
results ................................................................................................... 92 

1 

 
 
6.7.  Addressing  the  problem  that  a  mechanism  is  lacking  for  the 
identification of emerging chemical risks ........................................... 94 

ANNEX 1: PROCEDURAL INFORMATION .................................................... 95 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES ............................ 95 

2.  ORGANISATION AND TIMING ................................................................ 95 

3.  EVIDENCE, SOURCES AND QUALITY ................................................... 95 

ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ........ 97 

ANNEX 3: TRANSPARENCY AND CONFIDENTIALITY RULES .............. 101 

2 

 
 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

ACT 

CLP 

DGM 

ECHA 

EEA 

EFSA 

EMA 

EREN 

EQS 

FAIR 

FTE 

HBLV 

INCI 

Activities Coordination Tool 

Classification, labelling and packaging 

Data generation mechanism 

European Chemicals Agency 

European Environment Agency 

European Food Safety Authority 

European Medicines Agency 

Emergency Response Experimentation Network 

Environmental quality standard 

Findable, Accessible, Interoperable and Reusable 

Full-time equivalent 

Health-based limit value 

International nomenclature of cosmetic ingredients 

IPCHEM 

Information platform on chemical monitoring 

JRC 

LUCAS 

MRL 

Joint research centre 

Land Use/Cover Area frame statistical Survey 

Maximum residue limit 

3 

 
 
 
OECD 

OEL 

OHT 

PACT 

PARC 

POP 

Organisation 
Development 

for  Economic  Co-operation 

and 

Occupational exposure limit 

OECD harmonised template 

Public Activities Coordination Tool 

Partnership for the Assessment of Risk from Chemicals 

Persistent organic pollutant 

4 

 
 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

1.1. 

Political context 

Chemicals are everywhere in our daily lives and play a fundamental role in most of our 
activities. They form part of virtually every product we use for our well-being, the products 
we  use  to  protect  our  health  and  security,  and  the  innovative  solutions  to  meet  new 
challenges. The EU is the second largest producer of chemicals in the world with EUR 541 
billion  turnover  in  2018 (7.0%  of  EU  manufacturing  by  turnover)  and  14.4%  of  global 
sales in 2020 (CEFIC, 2022)1 and chemicals manufacturing is the fourth largest industry 
in  the  EU  comprising  30  000  companies,  95%  of  which  are  SMEs,  directly  employing 
approximately 1.2 million people and 3.6 million indirectly.   

At the same time, chemicals can cause harm to human health and the environment. Certain 
chemicals can cause cancers, affect the immune, respiratory, endocrine, reproductive and 
cardiovascular  systems  and  increase  our  vulnerability  to  disease.  Exposure  to  these 
harmful chemicals is therefore a threat to human health. In addition, chemical pollution of 
the environment is one of the key drivers putting the earth at risk2, affecting and amplifying 
planetary crises such as climate change, degradation of ecosystems and loss of biodiversity. 
Examples of these effects are the negative effects chemicals have on pollinators, insects, 
aquatic ecosystems, and on the bird population. 

The European Union has developed a comprehensive regulatory framework for chemicals. 
The aim is to provide a high level of protection of human health and the environment from 
the  adverse  effects  of  chemicals  and  to  support  the  efficient  functioning  of  the  internal 
market for chemicals while promoting the competitiveness and innovation of EU industry. 
A fitness check of the most relevant chemicals legislation (excluding REACH) (‘fitness 
check’)3 assessed over 40 pieces of legislation. It concluded that overall, the EU chemicals 
regulatory framework delivers results as intended and is fit-for-purpose. However, it found 
a  number  of  significant  weaknesses  that  prevent  the  framework  from  achieving  its  full 
potential. If not rapidly addressed, the framework will struggle to cope effectively with the 
risks posed by existing and new chemicals.  

The EU chemicals regulatory framework has the overall objective to provide high-level 
protection  of  human  health  and  the  environment  from  exposure  to  chemicals.  The  risk 
management processes introduced by each piece of legislation draw heavily from scientific 
and technical assessments of chemicals’ properties, their uses, exposure and risks and of 
the socio-economic consequences of the risk management measures planned.  

To conserve natural resources and protect ecosystems and people, within the limits of our 
planet, assessing the environmental impacts generated by chemicals along their entire life 
cycle  is  needed.  Evaluation  of  several  impact  categories,  such  as  climate  change  and 
resource  use,  requires  access  to  robust  and  high-quality  information  and  can  guide  the 
design,  development  and  production  of  chemicals  that  provide  a  desirable  function  or 

1  

2  

3  

Within the EU, two thirds of these sales are generated in four Member States: Germany (32.1%),  
France (13.5%), Italy (10.7%) and the Netherlands (8.9%) (CEFIC, 2022). See Annex 18 for more 
information on the chemical sector in the EU. 
Rockström,  J.  et  al.,  Planetary  Boundaries:  Exploring  the  Safe  Operating  Space  for  Humanity. 
Ecology and Society, 2009. 
Fitness Check of the most relevant chemicals legislation (excluding REACH). 

5 

 
 
 
service  while  being  safe  and  sustainable.  Moreover,  availability  of  sustainability 
information could trigger the demand for chemicals with lower environmental impacts, 
and therefore have direct benefit for health and the environment.  

To prevent harm caused by harmful chemicals, it is also essential to be able to identify as 
early as possible any emerging chemical risks and to anticipate unforeseen consequences 
related to the use of chemicals and their release into the environment. This requires having 
information on early warning signals.  

Building on the findings of the fitness check, the Commission committed in the European 
Green Deal4 to present a chemicals strategy for sustainability5 (‘the strategy’). As part of 
this work, it committed to start using the ‘one substance – one assessment’ approach to 
improve  the  efficiency,  effectiveness,  coherence  and  transparency  of  issuing  safety 
assessments of chemicals across different pieces of EU legislation.  

The one substance, one assessment approach focuses on the main factors influencing the 
efficiency, effectiveness, coherence and transparency of safety assessments. It covers: 

- 

Initiation  of  chemicals  safety  assessments.  This  means  synchronising  and 
coordinating the initiation or triggering of assessments to the extent possible and 
assessing groups of substances instead of assessing each substance individually to 
the extent possible. 

-  Allocation of tasks. This involves allocating clear responsibilities for performing 
assessments in such a way that best use is made of available expertise and resources 
and a good cooperation among all parties involved. 
Information. Ensuring that information is easily findable, accessible, interoperable, 
secure, of high quality and shared and reused to ensure that assessors have access 
to all available data without technical or administrative burden. 

- 

-  Methodologies.  The  methods  used  for  the  assessments  are  coherent  and  to  the 

extent possible harmonised. 

-  Transparency. Ensuring a high level of transparency in performing assessments as 

well as in the underlying scientific data and information on chemicals. 

To enable  the design,  production and use of  chemicals  that are safe  and  sustainable by 
design, and throughout their life cycle, the strategy announced that the Commission would 
develop  criteria  for  chemicals  that  are  ‘safe  and  sustainable  by  design’.  To  that  end,  a 
comprehensive assessment of both safety and sustainability throughout the whole life cycle 
of chemicals is required6. 

To strengthen the science-policy interface, the strategy announced that the Commission 
would develop an early warning and action system for chemicals to ensure that EU policies 
address emerging chemical risks as soon as identified by monitoring and research. It also 
announced that the Commission would develop a framework of indicators to monitor the 

4  
5  
6   

The European Green Deal. COM (2019) 640 final. 
The Chemicals Strategy for Sustainability. COM (2020) 667 final. 
Commission Recommendation (EU) 2022/2510 (https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32022H2510). 

6 

 
 
 
 
drivers and impacts of chemical pollution and to measure the effectiveness of chemicals 
legislation.   
The EU action plan Towards Zero Pollution for Air, Water and Soil7 (‘the EU action plan’) 
contributed to  the  strategy’s  objectives  by  committing to  developing an integrated zero 
pollution  monitoring  and  outlook  framework.  It  also  consolidated  the  roles  of  the 
European  Environment  Agency  (EEA)  and  the  Commission’s  Joint  Research  Centre  in 
close  collaboration  with  the  European  Chemicals  Agency  (ECHA),  the  European  Food 
Safety  Authority  (EFSA),  the  European  Maritime  Safety  Agency  and  other  relevant 
agencies as the EU’s knowledge centres of excellence for the zero-pollution monitoring 
and outlook framework.  

In  addition,  the  EU  action  plan  and  the  proposal  for  a  regulation  on  establishing  a 
framework  for  setting  ecodesign  requirements  for  sustainable  products8  emphasise  the 
commitment to ensure that chemicals and materials are as safe and sustainable as possible 
by design and during their life cycle, so that material cycles are non-toxic.  

To fulfil the commitment to start using the one substance, one assessment approach and in 
order to collate relevant information on the safety and sustainability of chemicals and on 
early warning signals for chemicals risks, the strategy identified the following actions:  

-  develop a common open data platform on chemicals9 to facilitate the sharing, 

access and re-use of information on chemicals coming from all sources. 

-  Promote the re-use and harmonisation of human and environmental health-based 
limit  values  among  EU  risk  assessors  and  managers  through  a  centralised  and 
curated EU repository. 

-  Establish tools and practices to ensure that relevant academic data is easily and 
readily accessible for safety assessments and is suitable for regulatory purposes. 
-  Enable  EU  and  national  authorities  to  commission  testing  and  monitoring  of 
substances  as  part  of  the  regulatory  framework  when  further  information  is 
considered necessary.  

-  Remove legislative obstacles for the re-use of data and better streamline the flow 

of chemicals data between EU and national authorities.  

-  Extend the principle of open data and the relevant transparency principles from 

the EU food safety sector to other pieces of chemical legislation. 

-  Develop an EU early warning and action system for chemicals to ensure that EU 
policies address emerging chemical risks as soon as identified by monitoring and 
research. 

-  Develop a framework of indicators to monitor the drivers and impacts of chemical 

pollution and to measure the effectiveness of chemicals legislation. 

7   
8  

9   

   The EU Action Plan ‘Towards Zero Pollution for Air, Water, and Soil. COM/2021/400 final. 

Proposal for a  regulation of the European Union and of the Council  establishing a framework for 
setting  ecodesign  requirements  for  sustainable  products  and  repealing  Directive  2009/125/EC. 
COM(2022) 142 final. 
As  part  of  the  European  Green  Deal  data  space  announced  under  the  EU  data  strategy. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions: A European Strategy for Data. 
COM (2020) 66 final. 

7 

 
 
 
The  European  Parliament  resolution10  of  10  July  2020  welcomed  the  strategy    and  the 
application of the one substance, one assessment principle in  order to  better use the 
resources  of  the  Union’s  agencies  and  scientific  bodies,  avoid  duplication  of  efforts, 
including testing, reduce the risk of diverging outcomes of assessments, speed up and bring 
consistency  and  transparency  to  chemicals  regulation,  and  ensure  enhanced  health  and 
environmental protection and a level playing field for industry, while taking into account 
the special situation of SMEs. The European Parliament initiated a project to assess the 
feasibility  of  consolidating  the  chemicals  data  collected  by  the  institutions,  bodies  and 
agencies of the European Union.  

The European Parliament’s resolution also called on the Commission to establish a fully 
connected  and  interoperable  EU  chemical  safety  database  so  as  to  facilitate  the 
seamless  sharing  of  data  between  authorities  and  provide  public  access  to  researchers, 
regulators, industry and the citizens at large. Moreover, the resolution stressed the need to 
develop ‘safe and sustainable by design’ criteria to help prevent and control pollution, 
improve the tracing of hazardous chemicals in products, and promote their substitution by 
safer and more sustainable alternatives.  
The Council conclusions11 of 15 March 2021 also welcomed the strategy and the aim of 
the one substance, one assessment approach to simplify and improve the transparency of 
the regulatory framework for hazard and risk assessment of chemicals while emphasising 
that this approach should not create delays in regulatory actions nor increase administrative 
burden. The conclusions highlighted the relevance of a comprehensive information base 
on chemicals and on chemicals’ overall environmental footprint, including their impact on 
the  climate,  biodiversity  and  marine  environment.  The  conclusions  also  welcomed  the 
establishment  of  an  EU  chemical  early  warning  and  action  system  and  called  for  the 
development,  in  collaboration  with  the  Member  States,  of  a  comprehensive  chemicals 
monitoring  framework  as  part  of  a  wider  zero  pollution  monitoring  and  outlook 
framework, with publicly accessible results, to oversee the driving forces and impacts of 
chemical pollution on human health and the environment, to complement monitoring of 
the presence of chemicals in ecosystems, and to measure the effectiveness of chemicals 
legislation.  

1.2.  Legal context 

This  initiative  complements  the  body  of  EU  law  governing  chemicals.  In  addition,  it 
complements or is consistent with several specific legal provisions under specific pieces 
of  chemicals-related  legislation.  It  covers  a  very  large  number  of  Union  chemicals 
legislations (listed in section 1.3).  

The proposed provisions on setting up a common data platform on chemicals and dedicated 
services  provided  by  that  platform  complement  existing  provisions  on  databases, 
repositories or platforms containing chemicals-related information issued under specific 
pieces of legislation. The common data platform will centralise and consolidate data on 
chemicals  at  EU  level  in  one  centrally  accessible  IT  infrastructure.  The  proposed 
provisions  also  build  on  a  project  initiated  by  the  European  Parliament  to  assess  the 

10  

11  

The European Parliament resolution of 10 July 2020 on the Chemicals Strategy for Sustainability. 
(2020/2531(RSP). 
The Council Conclusions on Sustainable Chemicals Strategy of the Union: Time to Deliver.  

8 

 
 
 
feasibility of consolidating the data on chemicals collected by EU institutions, bodies and 
agencies. 

The proposed provisions related to the dedicated service under the common data platform 
on  regulatory  information  will  integrate  existing  practices  on  disseminating  regulatory 
process information by the ECHA and EFSA, notably the Public Activities Coordination 
Tool7 and OpenEFSA8. The provisions are consistent with the proposals made to revise 
Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and 
mixtures and the proposal for a directive amending Directive 2000/60/EC establishing a 
framework for Community action in the field of water policy, Directive 2006/118/EC on 
the  protection  of  groundwater  against  pollution  and  deterioration  and  Directive 
2013/39/EU  as  regards  priority  substances  in  the  field  of  water  policy,  which  oblige 
authorities to inform the ECHA on regulatory processes they intend to start or have started. 

The  measures  to  set  standard  data  formats  and  controlled  vocabularies  by  EU  agencies 
(section 4.2.2) are consistent with and complementary to provisions under:  

−  Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation 
and  Restriction  of  Chemicals  (REACH),  establishing  a  European  Chemicals 
Agency (Articles 77 and 111);  

−  Regulation (EU) 528/2012 concerning the making available on the market and use 

of biocidal products (Articles 76 and 79);  

−  Commission  Implementing  Regulation  (EU)  2021/428  adopting  standard  data 
formats for the submission of applications for the approval or the amendment to 
the conditions of approval of active substances, as provided for in Regulation (EC) 
No 1107/2009 (Articles 1 and 2);  

−  Regulation (EC) 178/2002 laying down the general principles and requirements of 
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures in matters of food safety (Articles 39f and 39g) and  

−  Council  Regulation  (EEC)  No  1210/90  on  the  establishment  of  the  European 
Environment Agency and the European Environment Information and Observation 
Network (Annex A). 

The  proposed  provisions  on  the  use  by  authorities  of  chemicals  data  and  information 
contained in the common data platform aim to align chemicals acts with EU policies on 
data, including the European strategy for data12 and the Interoperable Europe Act13.  

The  proposed  provisions  on  the  notification  of  studies  commissioned  or  carried  out  by 
business operators are consistent with a similar notification obligation stipulated in Article 
32b  of  Regulation  (EC)  178/2002  for  studies  commissioned  or  carried  out  by  business 
operators to support an application or notification in food-related areas.  

12   

13  

Communication  from  the  Commission  to  the  European  Parliament,  The  Council,  The  European 
Economic and Social Committee and the Committee of the Regions, A European strategy for data, 
COM/2020/66 final. 
Proposal for a Regulation of the European Parliament and of the Council laying down measures for a 
high level of public sector interoperability across the Union (Interoperable Europe Act) COM(2022) 
720 final. 

9 

 
 
 
The  establishment  of  a  data  generation  mechanism  is  consistent  with  Article  32  of 
Regulation (EC) 178/2002, which states that the EFSA shall commission scientific studies 
necessary for the performance of its mission.  

The  establishment  of  a  database  on  environmental  sustainability-related  information  is 
complementary  to  Article  19a  of  Directive  (EU)  2022/24649  setting  the  reporting 
requirements needed to understand an undertaking’s impacts on sustainability matters, and 
the information needed to understand how sustainability matters affect the undertakings’ 
development, performance and market position and are relevant to the proposed Ecodesign 
for  Sustainable  Products  Regulation14.  The  aim  of  the  Ecodesign  Regulation  is,  among 
others,  to  create  harmonised  reporting  obligations  for  environmental  sustainability 
information along the value chain. 

This initiative relates to the proposal under preparation for a regulation on re-allocating the 
work  on  chemicals  between  EU  agencies  to  ensure  consistency  in  the  assessment  of 
chemicals  and  to  improve  efficiency.  That  proposed  regulation  makes  targeted 
amendments to the allocation of tasks in Directive 2011/65/EU on the restriction of the use 
of certain hazardous substances in electrical and  electronic equipment, Regulation (EU) 
2019/1021  on  persistent  organic  pollutants  and  Regulation  (EU)  2017/745  on  medical 
devices.  The proposal  also  amends Regulation  (EC) No 401/2009  establishing  the  EEA 
and Regulation (EC) No 178/2002. The aim is to ensure good cooperation between EU 
agencies on all aspects affecting the coherence and efficiency of assessment of chemicals 
(such as methodology development, exchange of data and solving divergences in scientific 
output).   

The proposal also relates to the proposal in preparation for a founding regulation of the 
ECHA, which aims to strengthen the ECHA’s governance and adapt it to its future role 
and  which  aims  to  streamline  the  working  methods  of  ECHA  bodies  and  make  their 
financing more sustainable. 

1.3. 

Scope of the document 

This  document  summarises  the  actions  taken  to  support  the  implementation  of  the  one 
substance, one assessment  approach, in  particular  in relation  to the improvement of the 
efficiency, effectiveness, coherence and transparency of safety assessments of chemicals 
across  EU  chemicals  legislation.  It  accompanies  the  horizontal  legislative  proposal 
formalising those actions. The document explains how the actions proposed contribute to 
achieving  the  one  substance,  one  assessment  objectives  and  the  establishment  of  a 
monitoring and outlook framework for chemicals. It provides an assessment of the impact 
of those actions where relevant. Where possible, a quantitative assessment is made.  

The specific pieces of legislation considered in scope of the legislative initiative are listed 
below. For some pieces of legislation only a limited set of specific actions proposed in this 
document is considered applicable. Those legislations are situated in the pharmaceuticals 
sector and are listed in a separate list below.   

14  

Proposal for a regulation of the European Union and of the Council establishing a framework for 
setting  ecodesign  requirements  for  sustainable  products  and  repealing  Directive  2009/125/EC. 
COM(2022) 142 final. 

10 

 
 
 
The  development  of  the  legislative  proposal  and  this  staff  working  document  was 
supported by a study titled ‘Study on streamlining chemicals data flows, increasing data 
interoperability,  dissemination,  re-use  and  the  use  of  all  available  data,  and  on  the 
establishment of a data generation mechanism for the purpose of safety assessments in the 
context  of  the  European  chemicals  regulatory  framework’.    The  proposal  for  the 
establishment  of  a  common  data  platform  was  supported  by  a  feasibility  study  on  a 
common  open  data  platform  on  chemical  safety  data15  and  builds  on  an  earlier  project 
initiated by the European Parliament to assess the feasibility of consolidating the chemical 
data collected by the institutions, bodies and agencies of the European Union. The proposal 
for the early warning and action system for emerging chemical risks was supported by a 
study  titled  ‘Pilot  of  an  EU  early  warning  system  for  emerging  chemical  risks  to  the 
environment’16.  

List of EU legislation in scope of this initiative 

1.  Council  Directive  91/271/EEC  of  21  May  1991  concerning  urban  waste  water 

treatment (OJ L 135, 30.5.1991, p. 40) 

2.  Council Directive 91/676/EEC of 12 December 1991 concerning the protection of 
waters  against  pollution  caused  by  nitrates  from  agricultural  sources  (OJ  L  375, 
31.12.1991, p.1) 

3.  Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community 

procedures for contaminants in food (OJ L 037, 13.2.1993, p.1) 

4.  Council Directive 98/24/EC of 7 April 1998 on the protection of workers from the 
risks related to chemical agents at work (fourteenth individual Directive within the 
meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11) 
5.  Directive 2004/37/EC of the European Parliament  and of the Council of 29 April 
2004 on the protection of workers from the risks related to exposure to carcinogens 
or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) 
of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p.50) 

6.  Directive  2000/53/EC  of  the  European  Parliament  and  of  the  Council  of  18 

September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34) 

7.  Directive 2000/60/EC of the European Parliament and of the Council of 23 October 
2000 establishing a framework for the Community action in the field of water policy 
(OJ L 327, 22.12.2000, p.1) 

8.  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 
2001  on  the  deliberate  release  into  the  environment  of  genetically  modified 
organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1) 
9.  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 
January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  the  European  Food  Safety  Authority  and  laying  down  procedures  in 
matters of food safety (OJ L 031, 1.2.2002, p. 1) 

10.  Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 

on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10) 

15  

16  

Feasibility study on a common open platform on chemical safety data - Publications Office of the 
EU (europa.eu) 
Pilot of an EU early warning system for emerging chemical risks to the environment.  

11 

 
 
 
 
 
11.  Directive  2002/46/EC  on  the  approximation  of  the  laws  of  the  Member  States 

relating to food supplements (OJ L 183, 12.7.2002, p. 51) 

12.  Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 
September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1) 
13.  Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 
September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 
29) 

14.  Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 
November 2003 on smoke flavourings used or intended for use in or on foods (OJ L 
309, 26.11.2003, p. 1) 

15.  Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 

February 2004 on drug precursors (OJ L 047, 18.2.2004, p. 1) 

16.  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 
April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 
30.4.2004, p. 55) 

17.  Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 

March 2004 on detergents (OJ L 104, 8.4.2004, p. 1) 

18.  Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 

April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1) 

19.  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 
October 2004 on materials and articles intended to come into contact with food and 
repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4) 
20.  Directive  2004/107/EC  of  the  European  Parliament  and  of  the  Council  of  15 
December  2004  relating  to  arsenic,  cadmium,  mercury,  nickel  and  polycyclic 
aromatic hydrocarbons in ambient air (OJ L 023, 26.1.2005, p. 3) 

21.  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 
February 2005 on maximum residue levels of pesticides in or on food and feed of 
plant  and  animal  origin  and  amending  Council  Directive  91/414/EEC  (OJ  L  070, 
16.3.2005, p. 1) 

22.  Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 
January  2006  concerning  the  establishment  of  a  European  Pollutant  Release  and 
Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ 
L 033, 4.2.2006, p. 1) 

23.  Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the 
methods of sampling and analysis for the official control of the levels of mycotoxins 
in foodstuffs (OJ L 070, 9.3.2006, p. 12) 

24.  Commission  Directive  2006/37/EC  of  30  March  2006  amending  Annex  II  to 
Directive 2002/46/EC of the European Parliament and of the Council as regards the 
inclusion of certain substances (OJ L 94, 1.4.2006, p. 32) 

25.  Commission  Regulation  (EC)  No  1882/2006  of  19  December  2006  laying  down 
methods of sampling and analysis for the official control of the levels of nitrates in 
certain foodstuffs (OJ L 364, 20.12.2006, p. 25) 

26.  Directive  2006/118/EC  of  the  European  Parliament  and  of  the  Council  of  12 
December 2006 on the protection of groundwater against pollution and deterioration 
(OJ L 372, 27.12.2006, p. 19) 

27.  Regulation  (EC) 1907/2006  of the European Parliament and of the Council of 18 
December  2006  concerning  the  Registration,  Evaluation,  Authorisation  and 
Restriction  of  Chemicals  (REACH),  establishing  a  European  Chemicals  Agency, 

12 

 
 
amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 
and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council  Directive 
76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC, and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1) 

28.  Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 
December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, 
p. 9) 

29.  Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 
December  2006  on  the  addition  of  vitamins  and  minerals  and  of  certain  other 
substances to foods (OJ L 404, 30.12.2006, p. 26) 

30.  Commission Regulation (EC) No 333/2007 laying down the methods of sampling 
and analysis for the official control of the levels of trace elements and processing 
contaminants in foodstuffs (OJ L 088, 29.3.2007, p. 29) 

31.  Directive 2007/2/EC of the European Parliament  and of the Council of 14 March 
2007  establishing  an  Infrastructure  for  Spatial  Information  in  the  European 
Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1) 

32.  Regulation (EC) No 108/2008 of the European Parliament and of the Council of 15 
January 2008 amending Regulation (EC) No 1925/2006 on the addition of vitamins 
and minerals and of certain other substances to foods (OJ L 39, 13.2.2008, p. 11) 

33.  Commission  Regulation  (EC)  No  353/2008  of  18  April  2008  establishing 
implementing rules for applications for authorisation of health claims as provided 
for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and 
of the Council (OJ L 109, 19.4.2008, p. 11) 

34.  Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for 
the implementation of Regulation (EC) No 1831/2003 as regards the preparation and 
the  presentation  of  applications  and  the  assessment  and  the  authorisation  of  feed 
additives (OJ L 133, 22.5.2008, p. 1) 

35.  Directive  2008/56/EC  of  the  European  Parliament  and  of  the  Council  of  17  June 
2008  establishing  a  framework  for  community  action  in  the  field  of  marine 
environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, 
p. 19) 

36.  Directive  2008/50/EC  of  the  European  Parliament  and  of  the  Council  of  21  May 

2008 on ambient air quality and cleaner air for Europe (OJ L 152, 11.6.2008, p. 1) 

37.  Directive  2008/98/EC  of  the  European  Parliament  and  of  the  Council  of  19 
November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 
3) 

38.  Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16 
December  2008  on  environmental  quality  standards  in  the  field  of  water  policy, 
amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 
84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the 
European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84) 

39.  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of chemicals of substances 
and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1) 

40.  Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 
December 2008 establishing a common authorisation procedure for food additives, 
food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1) 

13 

 
 
41.  Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 
December  2008  on  food  enzymes  and  amending  Council  Directive  83/417/EEC, 
Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 
2001/112/EC, and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p.7) 

42.  Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 

December 2008 on food additives (OJ L 354, 31.12.2008, p. 16) 

43.  Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 
December  2008  on  flavourings  and  certain  food  ingredients  with  flavouring 
properties  for  use  in  and  on  foods  and  amending  Council  Regulation  (EEC)  No 
1601/91,  Regulations  (EC)  No  2232/96  and  (EC)  No  110/2008  and  Directive 
2000/13/EC (OJ L 354, 31.12.2008, p. 34) 

44.  Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 
April 2009 on the European Environment Agency and the European Environment 
Information and Observation Network (OJ L 126, 21.5.2009, p. 13) 

45.  Directive 2009/32/EC of the European Parliament  and of the Council of 23 April 
2009 on the approximation of the laws of the Member States on extraction solvents 
used in the production of foodstuffs and food ingredients (OJ L 141, 6.6.2009, p. 3) 
46.  Directive  2009/48/EC  of  the  European  Parliament  and  of  the  Council  of  18  June 

2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1) 

47.  Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 
October 2009 laying down health rules as regards animal by-products and derived 
products  not  intended  for  human  consumption  and  repealing  Regulation  (EC)  No 
1774/2002 (OJ L 300, 14.11.2009, p. 1) 

48.  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 
October 2009 concerning the placing of plant protection products on the market and 
repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, 
p. 1) 

49.  Directive 2009/128/EC of the European Parliament and of the Council of 21 October 
2009 establishing a framework for Community action to achieve the sustainable use 
of pesticides (OJ L 309, 24.11.2009, p. 71) 

50.  Commission  Regulation  (EC)  No  1169/2009  of  30  November  2009  amending 
Regulation (EC) No 353/2008 establishing implementing rules for applications for 
authorisation of health claims as provided for in Article 15 of Regulation (EC) No 
1924/2006 of the European Parliament and of the Council (OJ L 314, 1.12.2009, p. 
34) 

51.  Commission  Regulation  (EC)  No  1170/2009  of  30  November  2009  amending 
Directive 2002/46/EC  of the European Parliament  and of Council and Regulation 
(EC) No 1925/2006 of the European Parliament and of the Council as regards the 
lists of vitamin and minerals and their forms that can be added to foods, including 
food supplements (OJ L 314, 1.12.2009, p. 36) 

52.  Directive  2009/148/EC  of  the  European  Parliament  and  of  the  Council  of  30 
November 2009 on the protection of workers from the risks related to exposure to 
asbestos at work (OJ L 330, 16.12.2009, p. 28) 

53.  Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 
November 2009 on the voluntary participation by organisations in a Community eco-
management  and  audit  scheme  (EMAS),  repealing  Regulation  (EC)  No  761/2001 
and Commission Decisions 2001/681/EC and 2006/193/EC (OJ L 342, 22.12.2009, 
p. 1) 

14 

 
 
54.  Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 

November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59) 

55.  Commission  Regulation  (EU)  No  257/2010  of  25  March  2010  setting  up  a 
programme  for  the  re-evaluation  of  approved  food  additives  in  accordance  with 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council on 
food additives (OJ L 080, 26.3.2010, p. 19) 

56.  Directive  2010/75/EU  of  the  European  Parliament  and  of  the  Council  of  24 
November 2010 on industrial emissions (integrated pollution prevention and control) 
(OJ L 334, 17.12.2010, p. 17) 

57.  Regulation  (EC) No 66/210  of the European Parliament and of the Council of 25 

November 2009 on the EU Ecolabel (OJ L 027, 30.1.2010, p. 1)  

58.  Commission  Regulation  (EU)  No  234/2011  of  10  March  2011  implementing 
Regulation  (EC)  No  1331/2008  of  the  European  Parliament  and  of  the  Council 
implementing Regulation (EC) No 1331/2008 establishing a common authorisation 
procedure  for  food  additives,  food  enzymes  and  food  flavourings  (OJ  L  064, 
11.3.2011, p. 15) 

59.  Commission  Regulation  (EU)  No  546/2011  of  10  June  2011  implementing 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council as 
regards  uniform  principles  for  evaluation  and  authorisation  of  plant  protection 
products (OJ L 155, 11.6.2011, p. 127) 

60.  Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 
on  the  restriction  of  the  use  of  certain  hazardous  substances  in  electrical  and 
electronic equipment (OJ L 174, 1.7.2011, p. 88) 

61.  Commission  Regulation  (EU)  No  1161/2011  of  14  November  2011  amending 
Directive 2002/46/EC  of the European Parliament  and of the Council, Regulation 
(EC) No 1925/2006 of the European Parliament and of the Council and Commission 
Regulation (EC) No 953/2009 as regards the lists of mineral substances that can be 
added to foods (OJ L 296, 15.11.2011, p. 29) 

62.  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 
October  2011  on  the  provision  of  food  information  to  consumers,  amending 
Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament 
and  of  the  Council,  and  repealing  Commission  Directive  87/250/EEC,  Council 
Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of 
the  European  Parliament  and  of  the  Council,  Commission  Directives  2002/67/EC 
and  2008/5/EC  and  Commission  Regulation  (EC)  No  608/2004  (OJ  L  304, 
22.11.2011, p. 18) 

63.  Commission  Implementing  Regulation  (EU)  No  307/2012  of  11  April  2012 
establishing implementing rules for the application of Article 8 of Regulation (EC) 
No  1925/2006  of  the  European  Parliament  and  of  the  Council  on  the  addition  of 
vitamins and minerals and of certain other substances to foods (OJ L 102, 12.4.2012, 
p. 2) 

64.  Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list  of 
permitted health claims made on foods, other than those referring to the reduction of 
disease risk and to children’s development and health (OJ L 136, 25.5.2012, p. 1) 

65.  Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 
May  2012  concerning  the  making  available  on  the  market  and  use  of  biocidal 
products (OJ L 167, 27.6.2012, p. 1) 

15 

 
 
66.  Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 
on the control of major-accident hazards involving dangerous substances, amending 
and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1) 
67.  Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 
on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38) 
68.  Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 
July  2012  concerning  the  import  and  export  of  hazardous  chemicals  (OJ  L  201, 
27.7.2012, p. 60) 

69.  Commission  Implementing  Decision  2013/63/EU  of  24  January  2013  adopting 
guidelines for the implementation of specific conditions for health claims laid down 
in Article 10 of Regulation (EC) No 1924/2006 of the European Parliament and of 
the Council (OJ L 22, 25.1.2013, p. 25) 

70.  Commission Regulation (EU) No 101/2013 of 4 February 2013 concerning the use 
of lactic acid to reduce microbiological surface contamination on bovine carcasses 
(OJ L 34, 5.2.2013, p. 1) 

71.  Commission  Regulation  EU  No  283/2013    of  1  March  2013  setting  out  the  data 
requirements  for  active  substances,  in  accordance  with  Regulation  (EC)  No 
1107/2009 of the European Parliament and of the Council concerning the placing of 
plant protection products on the market (OJ L 93, 3.4.2013, p. 1) 

72.  Commission  Regulation  EU  284/2013  of  1  March  2013  setting  out  the  data 
requirements for plant protection products,  in  accordance with  Regulation  EC  No 
1107/2009 concerning the placing of plant protection products on the market (OJ L 
93, 3.4.2013, p. 85) 

73.  Commission  Implementing  Regulation  (EU)  No  503/2013  on  applications  for 
authorisation of genetically modified food and feed in accordance with Regulation 
(EC) No 1829/2003 of the European Parliament and of the Council and amending 
Commission  Regulations  (EC)  No  641/2004  and  (EC)  No  1981/2006  (OJ  L  157, 
8.6.2013, p. 1) 

74.  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 
June 2013 on food intended for infants and young children, food for special medical 
purposes,  and  total  diet  replacement  for  weight  control  and  repealing  Council 
Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC 
and  2006/141/EC,  Directive  2009/39/EC  of  the  European  Parliament  and  of  the 
Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ 
L 181, 29.6.2013, p. 35) 

75.  Commission Implementing Regulation (EU) No 1321/2013 of 10 December 2013 
establishing the Union list of authorised smoke flavouring primary products for use 
as such in or on foods and/or for the production of derived smoke flavourings (OJ L 
333, 12.12.2013, p. 54) 

76.  Commission Regulation (EU) No 119/2014 of 7 February 2014 amending Directive 
2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 
1925/2006  of  the  European  Parliament  and  of  the  Council  as  regards  chromium 
enriched  yeast  used  for  the  manufacture  of  food  supplements  and  chromium  (III) 
lactate tri-hydrate added to foods (OJ L 39, 8.2.2014, p. 44) 

77.  Directive 2014/28/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of the laws of the Member States relating to the making 
available  on  the  market  and  supervision  of  explosives  for  civil  uses  (OJ  L  96, 
29.3.2014, p. 1) 

16 

 
 
78.  Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 
on the approximation of the laws, regulations and administrative provisions of the 
Member  States  concerning  the  manufacture,  presentation  and  sale  of  tobacco  and 
related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1) 

79.  Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 
April  2014  on  fluorinated  greenhouse  gases  and  repealing  Regulation  (EC)  No 
842/2006 (OJ L 150, 20.5.2014, p. 195) 

80.  Commission Regulation (EU) 2015/403 of 11 March 2015 amending Annex III to 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council as 
regards Ephedra species and Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex 
Beille) (OJ L 67, 12.3.2015, p. 4) 

81.  Regulation  (EU) 2015/2283  of the European Parliament and of the Council of 25 
November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the 
European Parliament and of the Council and repealing Regulation (EC) No 258/97 
of the European Parliament and of the Council and Commission Regulation (EC) No 
1852/2001 (OJ L 327, 11.12.2015, p. 1) 

82.  Directive  (EU)  2016/2284  of  the  European  Parliament  and  of  the  Council  of  14 
December  2016  on  the  reduction  of  national  emissions  of  certain  atmospheric 
pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ 
L 344, 17.12.2016, p. 1) 

83.  Commission Regulation (EU) 2017/644 of 28 March 2007 laying down methods of 
sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-
dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 589/2014 
(OJ L 92, 6.4.2017, p. 9) 

84.  Regulation  (EU)  2017/625  of  the  European  Parliament  and  of  the  Council  of  15 
March 2017 on official controls and other official activities performed to ensure the 
application of food and feed law, rules on animal health and welfare, plant health 
and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 
396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of 
the  Council,  Council  Regulations  (EC)  No  1/2005  and  (EC)  No  1099/2009  and 
Council  Directives  98/58/EC,  1999/74/EC,  2007/43/EC,  2008/119/EC  and 
2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 
of  the  European  Parliament  and  of  the  Council,  Council  Directives  89/608/EEC, 
89/662/EEC,  90/425/EEC,  91/496/EEC,  96/23/EC,  96/93/EC  and  97/78/EC  and 
Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 095, 7.4.2017, 
p. 1) 

85.  Regulation  (EU)  2017/745  on  medical  devices,  amending  Directive  2001/83/EC, 
Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No  1223/2009  and  repealing 
Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1) 

86.  Commission  Regulation  (EU)  2017/1203  of  5  July  2017  amending  Directive 
2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 
1925/2006 of the European Parliament and of the Council as regards organic silicon 
(monomethylsilanetriol) and calcium phosphoryl oligosaccharides (POs-Ca®) added 
to foods and used in the manufacture of food supplements (OJ L 173, 6.7.2017, p. 9) 
87.  Commission  Implementing  Regulation  (EU)  2017/2470  of  20  December  2017 
establishing  the  Union  list  of  novel  foods  in  accordance  with  Regulation  (EU) 

17 

 
 
2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 
30.12.2017, p. 72) 

88.  Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 
2017  on  mercury,  and  repealing  Regulation  (EC)  No  1102/2008  (OJ  L  137, 
24.5.2017, p. 1) 

89.  Commission  Regulation  (EU)  2018/782  of  29  May  2018  establishing  the 
methodological  principles  for 
the  risk  assessment  and  risk  management 
recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, 
p. 5) 

90.  Regulation  (EU)  2019/4  of  the  European  Parliament  and  of  the  Council  of  11 
December  2018  on  the  manufacture,  placing  on  the  market  and  use  of  medicated 
feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the 
Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1). 
91.  Commission  Regulation  (EU)  2019/650  of  24  April  2019  amending  Annex  III  to 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council as 
regards Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) (OJ L 110, 
25.4.2019, p. 21) 

92.  Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 
2019  laying  down  rules  on  the  making  available  on  the  market  of  EU  fertilising 
products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and 
repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1) 

93.  Regulation  (EU) 2019/1021  of the European Parliament and of the Council of 20 

June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45) 

94.  Commission Implementing Regulation EU 2020/1740 of 20 November 2020 setting 
out  the  provisions  necessary  for  the  implementation  of  the  renewal  procedure  for 
active substances, as provided for in Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council, and repealing Commission Implementing Regulation 
(EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20) 

95.  Commission  Implementing  Regulation  (EU)  2020/1824  of  2  December  2020 
amending  Implementing  Regulation  (EU)  2017/2468  laying  down  administrative 
and  scientific  requirements  concerning  traditional  foods  from  third  countries  in 
accordance with Regulation (EU) 2015/2283 of the European Parliament and of the 
Council on novel foods (OJ L 406, 3.12.2020, p. 51) 

96.  Directive  (EU)  2020/2184  of  the  European  Parliament  and  of  the  Council  of  16 
December 2020 on the quality of water intended for human consumption (OJ L 435, 
23.12.2020, p. 1) 

97.  Regulation EU 2021/428 of 10 March 2021 adopting standard data formats for the 
submission of applications for the approval or the amendment to the conditions of 
approval of active substances, as provided for in Regulation (EC) No 1107/2009 of 
the European Parliament and of the Council (OJ L 84, 11.3.2021, p. 25) 

98.  Commission Regulation (EU) 2022/1616 on recycled plastic materials and articles 
intended  to  come  into  contact  with  foods,  and  repealing  Regulation  (EC)  No 
282/2008 (OJ L 243, 20.9.2022, p. 3) 

99.  Commission Regulation (EU) 2023/915  of 25 April 2023 on maximum levels  for 
certain  contaminants in  food and repealing Regulation  (EC) No 1881/2006  (OJ L 
119, 5.5.2023, p. 103) 

18 

 
 
 
List of Union legislation only partly in scope of this initiative17 

1.  Directive  2001/83/EC  on  the  Community  code  relating  to  medicinal  products  for 

human use   

2.  Regulation (EC) No 726/2004 laying down Union procedures for the authorisation 
and supervision of medicinal products for human and veterinary use and establishing 
a European Medicines Agency    

3.  Regulation (EU) 2019/6 on veterinary medicinal products   
4.  Regulation  (EC)  No  470/2009  laying  down  Community  procedures  for  the 
establishment of residue limits of pharmacologically active substances in foodstuffs 
of animal origin    

17  

Only specific types of data will be brought within the scope of the regulation and included in the 
common data platform for chemicals.  

19 

 
 
 
 
 
 
2.  PROBLEM DEFINITION 

2.1.  What is/are the problems? 

The  EU  regulatory  framework  for  hazard  and  risk  assessment  and  management  of 
chemicals  is  comprehensive.  It  consists  of  many  pieces  of  legislation,  addressing  the 
production and placing on the market of chemicals and chemical products, emissions of 
chemicals, protection of workers’ health and safety of consumer products, foodstuff and 
feedstuff, and the environment. A high volume of technical and scientific work supports 
he implementation of the individual legislative acts. Sustained EU contribution is provided 
also  for  flanking  measures18  supporting  policy  objectives  on  chemicals  in  addition  to 
legislative tools.  

Depending on the legislation, the work is initiated by various actors, at different points in 
time,  using  different  data  and  involving  different  actors  (EU  agencies,  scientific 
committees,  expert  groups,  Commission  services  and  contractors).  This  situation 
sometimes  leads  to  inefficient  use  of  resources  and  slow  procedures.  Differences  in 
knowledge base across pieces of legislation and incomplete knowledge bases may result 
in inconsistent outcomes for the same chemical. Similarly, different dissemination rules 
across  pieces  of  legislation  for  the  same  chemical  may  result  in  different  degrees  of 
transparency.  As  a  consequence,  the  predictability  for  stakeholders  and  the  general 
public is reduced.  

Despite the comprehensive and advanced EU regulatory framework for chemicals there is 
a growing concern that it lacks the relevant mechanisms to adequately address emerging 
chemical  risks  in  a  timely  manner.  There  are  numerous  examples  of  the  long  timespan 
between a signal of a risk and the adoption of adequate measures to address  that risk19. 
These  examples  also  illustrate  the  difficulty  to  get  emerging  chemical  risks  such  as 
nanomaterials,  PFAS  and  endocrine  disruptors  on  the  radar  of  policy  makers  and 
governmental risk assessors.  

An overview of the identified problems is given in Table 1 below. 

Table 1 – overview of identified problems 

Overall problem 

Specific problems 
Chemicals data is scattered 

Chemicals data is not always interoperable 

18  

19  

While this general description could fit many activities supported through instruments like LIFE or 
COSME, the noteworthy example is the existing Commission’s continued contribution to operation 
of EUON-European Observatory for nanomaterials, set as an alternative non-legislative solution to 
at the time considered EU registry of nanomaterials. EUON is operated by ECHA, commissioning 
studies,  and  compiling  available  information  to  increase  and  communicate  knowledge  on 
nanomaterials and increase transparency regarding their presence in the market. Commission staff 
working  document:  impact  assessment  accompanying  the  document  Commission  Implementing 
Decision on a Delegation Agreement with the European Chemicals Agency on the European Union 
Observatory  for  Nanomaterials  and  the  European  Union  Chemical  Legislation  Finder  in  the 
framework of the COSME programme. SWD (2017) 138 final.. 
EEA:  Late  lessons  from  early  warnings:  the  precautionary  principle  1896–2000,  Luxembourg: 
Office for Official Publications of the European Communities, 2001 

20 

 
 
 
 
 
2.1.1. Information is difficult to find, 
or share 

Chemicals data is not always accessible  

Academic data are insufficiently considered  

2.1.2. Knowledge base is incomplete 

Lack of availability of certain types of chemicals data 

Not all study results are reported by duty holders 

Lack of mechanism to identify emerging chemical risks 

2.1.1. Information is difficult to find, share or use 

that 

there  are  shortcomings 

The fitness check of the most relevant chemical legislation (excluding REACH)20 (‘Fitness 
Check’)  found 
in  the  findability,  accessibility, 
interoperability and availability of good-quality and reliable data and in sharing and 
using data across legislative silos. Stakeholders have complained about this in the past 
(e.g.  regarding  inefficiencies  caused  by  double  reporting  requirements,  difficulties  to 
identify and access data, inconsistencies between outcomes of safety assessments because 
they  are  based  on  different  datasets  -  which  are  frequently  not  interoperable  -  and  not 
considering  all  available  data  in  safety  assessments).  There  is  a  lack  of  awareness  of 
interested parties (EU bodies, authorities, industry, NGOs) of what information is available 
and  where  and  how  the  existing  data  can  be  used  and  accessed,  and  use  rights  are 
sometimes too restrictive. Unnecessary duplication of effort in data generation still occurs 
in  some  instances  due  to  a  lack  of  data  sharing  as  a  result  of  various  factors  including 
confidentiality and intellectual property rights. Technical obstacles, such as different data 
formats  and  different  vocabularies  for  the  same  chemical  under  different  pieces  of 
legislation, make data handling inefficient and are seen as contributing obstacles to the one 
substance, one assessment approach.  

Chemicals data is scattered and some information flows are suboptimal  
Through  the  EU’s  comprehensive  chemicals  legislative  framework  copious  amounts  of 
information about chemicals, their use and their occurrence are generated and collected by 
various  stakeholders,  including  industry,  the  Commission,  EU  agencies  and  Member 
States. However, individual data streams resulting from the implementation of individual 
pieces of legislation are not always interconnected and are hosted or stored in different 
databases and in different locations.  
In addition, some information flows are not optimal, e.g. because information is flowing 
to an agency which does not necessarily have the best expertise or does not have the type 
of  data  or  the  specific  piece  of  legislation  in  its  mandate.  Also,  some  information  is 
collected at Member State level but not shared with other Member States or EU agencies. 
This is particularly the case for raw data on monitoring of chemicals in the environment. 
Another example is the lack of long-term structures to store and assess data from EU-

20  

Report from the Commission to the European Parliament, the Council, the European Economic and 
Social  Committee  and  the  Committee  of  the  Regions  finding  of  the  Fitness  Check  of  the  most 
relevant chemicals legislation (excluding REACH) and identified challenges, gaps, and weaknesses. 
COM (2019) 264 final.  

21 

 
 
 
 
 
 
 
 
 
 
 
 
funded research projects or for certain voluntarily shared information, such as groundwater 
data on emerging pollutants.  
All  this  makes  it  difficult  for  safety  assessors  and  other  stakeholders  to  know  which 
information is available for a particular chemical and to find that information. Without a 
clear overview of what data is available and to which chemicals characteristics it relates, 
the EU safety assessor may not be able to use the existing wealth of information to its full 
potential.  This  may  lead  to  inefficient  assessments  and  decision  making,  but  also  to 
incoherent outcomes of different assessments of the same chemical, which in turn has a 
negative  impact  on  the  predictability  for  duty  holders  and  the  EU  citizen’s  trust  in  the 
sound and scientific underpinning of the EU’s assessment activities. 

Chemicals data is not always interoperable 
The feasibility study on a common open platform on chemical safety data21 revealed that 
slightly over 50% of the considered sources of chemicals data (i.e., different platforms, 
databases  or systems  related to  chemicals  information) provide data in  a  comparatively 
structured way (e.g., tables, etc), while the remaining sources use less structured formats 
(such as reports) to provide data. The analysis done in the context of the study supporting 
this  legislative  initiative on  chemicals  information  was  in  line  with  the  findings  of  that 
feasibility  study.  Many  different  -  not  always  well-defined  -  formats  are  used.  It  is 
recognised  that  the  importance  of  harmonised  formats  and  controlled  vocabularies  has 
increased over the last years.   
For  monitoring  data,  the  support  to  the  Fitness  Check  of  monitoring  and  reporting 
obligations  arising  from  EU  environmental  legislation22  states  that  almost  half  of  the 
identified reporting obligations have no format requirement. It should be noted, however, 
that not all monitoring data considered in that study are related to chemicals.   

Chemicals data is not always accessible and re-usable 
Differences exist in transparency rules governing the dissemination23 of chemicals data 
across  pieces  of  legislation.  Such  differences,  as  well  as  different  interpretations  of  the 
same  rules  by  different  agencies  or  authorities,  create  a  legal  obstacle  for  sharing  data 
among authorities. An agency with less stringent transparency rules may not be able to 
share its data with an agency with stronger transparency rules, because the latter would 
have to disseminate the information following its transparency rules while the agency with 
less stringent transparency rules does not have permission to disseminate such data. This 
obstacle hinders coherence and efficiency of chemicals safety assessments, as authorities 
are not always aware of or cannot see data held by other authorities and can therefore also 
not  consider  it  in  their  assessment.  Differences  in  transparency  rules  across  pieces  of 
legislation and agencies might also be seen as incoherent by the general public.  

21  
22  

23  

Feasibility study on a common open platform on chemical safety data. 
Study  to  support  the  Fitness  Check  of  environmental  monitoring  and  reporting  obligations:  a 
summary of public consultation responses.  
For the purpose of this initiative and staff working document, data dissemination is considered as 
the process of making information available to the general public, while data sharing is a term used 
for making data available to authorities. Transparency is about openness of data and information to 
the  general  public  and  transparency  rules  thus  govern  the  degree  of  dissemination  of  data  and 
information to the general public. Finally, data re-use refers to the use of data by actors which differ 
from the originator or owner of the data.  

22 

 
 
 
 
 
In order to ensure the coherence and effectiveness of chemical safety assessments across 
legislative silos in line with the objectives of the one substance, one assessment approach, 
it  is  important  that  authorities  have  the  right  to  re-use  data  in  the  assessments  where 
relevant24.  

2.1.2. Knowledge base is incomplete 

The knowledge base for regulatory safety assessments is not always complete. This may 
have  different  reasons:  duty  holders  may  not  report  all  results  of  the  studies  they 
commission or carry out, academic data are not always sufficiently considered, and the 
current  legal  framework  does  not  allow  for  or  does  not  standardly  require  the 
generation of certain data.  

Lack of availability of certain types of chemicals data 
Different  mechanisms  and  systems  exist  at  EU  and  Member  State  level  to  request  or 
generate data (via measurements or via non-testing and modelling methodologies) required 
for chemical  safety  and  risk  assessments, either  under legislative  frameworks or  within 
other contexts. Still, not all chemicals on the market and/or occurring in the environment 
have  currently  been  sufficiently  characterised  in  terms  of  their  toxicological  properties 
and/or exposure sources and pathways or are regularly monitored. In addition, the lack of 
robust  data  on  the  environmental  performance  of  chemicals  throughout  their  lifecycle 
limits the extent to which the impacts of chemicals on the environment are understood, and 
therefore hinders the EU’s ability to take targeted action to improve the sustainability of 
the industry by managing and reducing the environmental impact of chemicals. The sheer 
number of chemicals on the market represents an immense knowledge challenge, and the 
expected future rise in chemical production and use risks further widening the ‘unknown 
territory of chemical risks’. Under Regulation (EC) 178/2002, the European Food Safety 
Authority (‘EFSA’) is given the means to perform all the tasks required to enable it to carry 
out its role. This includes a mandate for the EFSA to carry out scientific studies where 
necessary. Such mandate or possibility does not exist for other agencies dealing with 
chemicals.  

Academic data are insufficiently considered  
The fitness check concluded that there is a need to improve the consideration of academic 
data when carrying  out  chemical  safety  assessments.  ‘Academic data’ is taken to  mean 
chemicals related data derived from scientific studies published in peer-reviewed literature. 
In EU chemicals legislation, the consideration of academic data is usually not explicitly 
addressed  but  rather  subsumed  in  the  requirement  to  consider  all  available,  relevant 
information. Academic studies are often not carried out according to the quality standards 
to which EU legislation refers, such as Good Laboratory Practice (GLP) and OECD test 
guidelines. This makes comparison difficult to data that are generated using such standard 

24  

For the purpose of this initiative, re-use focuses on the re-use of data by authorities (authorities 
are taken to mean the Commission, EU agencies and Member State competent authorities) (although 
data may come from different sources, such as from authorities, industry, or research activities). 
Re-use of data between private parties is not considered. This, however, does not constitute any 
barrier for industry to agree on business-to-business re-use for specific legal obligations or other 
purposes, as is already the case today. 

23 

 
 
 
 
test  guidelines.  Despite  peer  review,  the  appropriateness  of  data  published  in  academic 
journals for use in regulatory processes can be variable, meaning scrutiny is required to 
ensure that the data is relevant and reliable for regulatory risk assessment purposes. This 
evaluation of the reliability and relevance of academic data is a burdensome process. The 
European Commission highlighted in the fitness check the importance of academic data in 
the early identification of new information and data on hazards and pointed out the lack of 
tools for the continuous monitoring of scientific papers and publications. This may slow 
down the reaction time of regulation to risks and means that early warning signals may be 
missed. 

Not all study results are reported by duty holders 
Under certain pieces of chemicals legislation, the industry needs to either seek regulatory 
approval  or  submit  a  registration  before  placing  a  chemical  on  the  EU  market.  The 
registration/approval  is  typically  obtained  upon  the  submission  of  a  dossier  including 
supporting studies that are required by law. These supporting studies are commissioned 
with laboratories or carried out in-house. For assessors to be able to carry out their tasks 
properly, it is necessary that they have knowledge of all studies performed by an applicant 
or registrant. Yet, duty holders may withhold unfavourable results without assessors 
ever  being  aware  of  this.  Regulation  (EU)  2019/1381  on  the  transparency  and 
sustainability  of the EU  risk assessment in  the food chain  (“Transparency  Regulation”) 
which amended Regulation (EC) 178/2002 introduced the requirement for duty holders to 
notify  studies  to  the  EFSA  when  they  are  commissioned  or  carried  out  with  a  view  to 
submitting  an  application.  The  potential  problem  of  not  including  certain  studies  in  a 
dossier or application is likely not unique to the food sector and may equally occur in the 
rest of the chemicals sector.  

2.1.3. Lack of mechanism to identify emerging chemical risks 
The identification of new, emerging risks constitutes a major challenge to tackle. While it 
is important to ensure the prevention and management of existing risks, it is also essential 
to be able to anticipate as soon as possible to unforeseen consequences related to the use 
of chemicals and their release into the environment and to ensure that emerging risks are 
properly addressed in a timely manner by EU policy and decision makers. Some initiatives 
and projects already exist to this end, but are not comprehensive; their scope is limited or 
their funding is time-limited.  

Even  with  an  increase  of  the  available  information  on  early  warning  signals  for  the 
scientific  community  and  experts,  there  is  no  procedure  at  EU  level  for  a  systematic 
collaboration  with  policy  makers,  regulatory  agencies  and  monitoring  organisations  to 
facilitate  timely  follow-up  actions.  As  chemicals  production  is  expected  to  continue  to 
grow, new and legacy chemicals will continue to be released into the environment, adding 
to the total chemical burden on ecosystems and people. Unidentified risks of chemicals 
will continue to be a growing concern due the increasing speed at which novel chemicals 
and products are placed on the market.  

24 

 
 
 
 
2.2.  What are the problem drivers? 

This  section  describes  the  underlying  causes  (or  "drivers")  of  the  issues  and  problems 
described in section 2.1. Drivers are regulatory failures and technical obstacles. 

Specific problem 

Drivers 

Information is difficult 
to find or share: 
chemicals data is 
scattered and some 
information flows are 
suboptimal 
Information is difficult 
to find or share: 
chemicals data is not 
always interoperable 
Information is difficult 
to find or share or use: 
chemicals data is not 
always accessible and 
usable 

Incomplete knowledge 
base: lack of 
availability of certain 
types of chemicals data 

Incomplete knowledge 
base: academic data are 
insufficiently 
considered 

Incomplete knowledge 
base: not all study 
results are reported by 
duty holders 
Incomplete knowledge 
base: lack of 
mechanism to identify 
emerging chemical risks 

•  Pieces of legislation on chemicals are typically tailored to their specific 
objective without interconnection between them. Information is hosted or 
stored  in  different  locations  without  a  link  or  interaction  between  the 
locations or an overview of where chemicals data can be found 

•  Different pieces of legislation impose different or no standard formats and 

different or no controlled vocabularies 

•  Different  pieces  of  legislation  have  different  transparency  rules.  In 
addition, because of uncertainty on how to interpret confidentiality rules 
in some pieces of legislation, EU agencies apply precautionary measures 
and refrain from sharing information with other agencies or Member State 
competent authorities altogether 

•  In  many  pieces  of  chemicals  legislation,  the  use  of  information  for 
purposes  other  than  those  of  the  specific  legislation  at  hand  is  not 
considered.  

•  There  is  a  lack  of  possibility  for  the  Commission  or  an  EU  agency  to 
conduct  studies  where  necessary  to  support  the  implementation  and 
development of Union chemicals legislation or policy 

•  Reporting mechanisms, common data formats and controlled vocabularies 

for information related to environmental sustainability are lacking 

•  While  some  pieces  of  legislation  require  the  uptake  of  ‘all  available, 
relevant information’, thus including information coming from literature 
searches,  experience  shows  that  such  literature  searches  are  not  always 
carried out 

•  In  other  pieces  of  legislation,  there  is  no  –  direct  or  indirect  –  legal 

requirement to include information resulting from literature searches 

•  Chemicals data from peer reviewed publications is not always fit for use 
in  a  regulatory  context;  the  information  is  usually  generated  with  a 
predominant research purpose in mind and study designs and reporting do 
not always take into account regulatory needs. This may be the result of 
insufficient  knowledge  by  the  research  community  of  regulatory  needs 
and/or  of  the  lack  of  incentives  to  produce  peer  reviewed  publications 
which are also fit for use in a regulatory context 

•  A  mechanism  allowing  to  check  whether  studies  that  are carried  out or 
commissioned are also effectively included in a regulatory procedure or 
dossier is lacking 

•  The  coordination  of  the  identification  and  assessment  of  early  warning 
signals of emerging chemical risks to enable policy or regulatory follow 
up activities  is inadequate 

25 

 
 
 
3.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

3.1.  General objectives  

This initiative pursues a better-informed, more robust scientific decision-making in the EU 
that would allow to achieve a high level of protection of human health and the environment. 
It  aims  to  give  broader  access  to  and  encourage  the  use  by  public  authorities  in  the 
performance of regulatory functions and fulfilment of their missions of data on chemicals 
in the environment and on the presence and risk of chemicals in humans. In addition,  it 
aims  at  improving  the  functioning  and  effectiveness  of  the  governance  of  the  internal 
market for chemicals as the common data platform by providing information on planned, 
ongoing and completed regulatory processes on chemicals as well as information on legal 
obligations under Union acts on chemicals.  

3.2. 

Specific objectives 

The initiative should achieve the specific objectives detailed in Table 2 below linked to the 
problems and their respective drivers. 

Table 2 – Specific objectives related to the identified problems and their respective drivers 

Problem 

Objective 

Chemicals data is scattered and some information 
flows are suboptimal 

Establish a central platform containing or linking to 
chemicals  data  resulting  from  the  implementation 
of EU chemicals legislation and from national and 
international 
research 
programs 

implementation 

and 

Chemicals data is not always interoperable 

Chemicals  data  is  not  always  assessable  and 
usable 

Academic studies are insufficiently considered 

Enable findability and interoperability of chemicals 
data 

Make  chemicals  data  available  in  a  transparent 
manner to different types of users and enable use of 
the  information  by  Member  States,  EU  agencies 
and the Commission under pre-defined conditions 

Improve 
chemicals safety and risk assessments 

the  uptake  of  academic  studies 

in 

Lack of availability of certain types of chemicals 
data 

Establish  a  mechanism  for  EU  agencies  to  obtain 
adequate data and information 

Duty holders may not report all study results 

Ensure  that  information  is  shared  on  planned 
studies before they are being carried out 

Lack of mechanism to identify emerging chemical 
risks 

Establish  an  EU  early  warning  and  action  system 
for emerging chemical risks 

3.2.1.  Objectives  related  to  the  problem  that  chemicals  data  is  scattered  and  some 
information flows are suboptimal 

26 

 
 
 
 
 
Bring together chemicals data: The objective is to establish a central platform containing 
or linking to chemicals data resulting from the implementation of EU chemicals legislation 
and from national and international implementation and research programs. This calls for 
an efficient flow of information from EU agencies, the Commission, and in one particular 
instance also  the Member States,  to  such platform. This  objective builds  on the project 
initiated by the European Parliament to assess the feasibility of consolidating the chemicals 
data collected by the institutions, bodies and agencies of the European Union.  

3.2.2.  Objectives  related  to  the  problem  that  chemicals  data  is  not  always 
interoperable 

Ensure  interoperability  of  chemicals  data:  The  objective  is  to  enable  findability, 
harmonisation and interoperability of chemicals data by encoding them in standard formats 
and by using controlled vocabularies.  

3.2.3. Objectives related to the problem that chemicals data is not always accessible 
and usable 

Make  chemicals  data  accessible  and  usable:  The  objective  is  to  make  chemicals  data 
available in a transparent manner to different types of users and to enable use of the data 
by Member States, EU agencies and the Commission under pre-defined conditions.  

3.2.4.  Objectives  related  to  the  problem  that  academic  data  is  insufficiently 
considered 

Improve  the  uptake  of  academic  studies:  The  objective  is  to  improve  the  uptake  of 
academic  studies  in  chemicals  safety  and  risk  assessments.  This  calls  for  new  or 
strengthened regulatory requirements and clarity for researchers and publishers on what 
type of information and reporting is relevant and necessary for use for regulatory purposes. 

3.2.5. Objectives related to the problem that there is a lack of availability of certain 
types of chemicals data 

Establish a data generation mechanism: The objective is to establish a mechanism for EU 
agencies to obtain adequate data and information required for the assessment of safety and 
impacts of chemicals in an efficient and coherent way, while maintaining the principle that 
the burden of proof of the safety of chemicals is on industry.  

3.2.6. Objectives related to the problem that duty holders may not report all study 
results  

Ensure notification of studies before they are commissioned or carried out: The objective 
is to ensure that information is shared on planned studies before they are being carried out 
and commissioned and before it is known whether results are favourable or not.  

3.2.7.  Objectives  related  to  the  problem  that  a  mechanism  is  lacking  for  the 
identification of emerging chemical risks 

Establish  an  EU  early  warning  and  action  system  for  emerging  chemical  risks:  The 
objective  is  to  establish  a  proactive  and  systematic  approach  to  the  identification  of 

27 

 
 
emerging  risks  by  developing  and  compiling  early  warning  signals  and  drawing  up 
summary reports to inform policy and regulatory follow up activities. 

4.  WHAT ARE THE AVAILABLE OPTIONS? 

4.1.  What is the baseline from which options are assessed? 

In the absence of this legislative initiative, the current data submission practices, data flows 
and data hosting and storage practices under existing chemicals legislation would continue 
to apply. The same accounts for existing practices with regard to the uptake of academic 
data,  the  use  of  data  generation  mechanisms  and  the  application  of  study  notification 
requirements. In the sections below, a short description is given of what this means more 
concretely.  Given  the  vast  number  of  pieces  of  legislation  covered  by  this  initiative,  a 
detailed description of the current practice for each piece of legislation would lead us too 
far for the purpose of a staff working document, so for some sections (in particular the one 
related  to  data  flows)  examples  are  given  to  demonstrate  concrete  issues  and  practices. 
More detailed information on the current practice under the various pieces of legislation is 
given in the study supporting this initiative.   

4.1.1. Data flows 

A comprehensive assessment of the status of the chemicals data landscape was made in 
the feasibility study on a common open platform on chemical safety data25. There is a large 
amount of chemicals data in databases, much of it compiled following legal provisions and 
used  in  own  processes  but  also  disseminated  by  EU  agencies  and  the  Commission  for 
transparency  and  public  use.  Comprehensive  IT  development  has  taken  place  in  the 
agencies, optimizing tools used for internal data within sectors, in specific circumstances 
also using common building blocks (e.g. IUCLID for information on chemical hazards). 
The Information Platform on Chemical Monitoring (IPCHEM26) was developed for use 
across sectors but is limited to chemical occurrence data.  

Effective  common  access  to  different  types  of  chemicals  data  across  those  IT 
infrastructures  has  however  not  been  enabled  and  is  therefore  also  not  systematically 
applied  in  EU  chemicals  assessments.  Also,  any  ad  hoc  integration  of  information  is 
hampered  by  different  use  conditions  and  differences  in  data  formats  and  controlled 
vocabularies. There is inefficiency and duplication as individual projects repeat the same 
efforts  merging  and  curating  certain  data  across  sectors  for  specific  needs  (e.g.  the 
validation of predictive tools). There is also loss of coherence or there is even divergence 
between assessments of the same substances or groups of substances due to differences in 
the datasets used. 

Different  information  types  and  datasets  relevant  for  chemical  safety  assessments  are 
collected under the various pieces of EU chemicals legislation in the scope of this initiative. 
Depending  on  the  legislation,  the  obligation  to  collect  information  is  on  business 
operators, Member States and/or EU agencies.  

25   
26  

Feasibility study on a common open platform on chemical safety data.  
Information Platform for Chemical Monitoring (IPCHEM).  

28 

 
 
 
Although not always the case, the data is usually reported to a Member State, EU agency 
or the Commission. Data flows are usually determined in legislation and typically have a 
recipient with a mandate or expertise corresponding to the type of data (e.g. data on food 
related chemicals typically flows to the EFSA, while information on medicinal chemicals 
and products typically flows to the EMA).  

Information  may  be  submitted  in  a  standard  format  (imposed  through  legislation  or 
deployed in practice) or without any specified format.  

Data are typically hosted or stored in databases that are established and maintained by the 
receiving parties (Member States, EU agencies, Commission), without interaction or a link 
necessarily between the different existing databases, repositories, platforms etc.  

Rules for the dissemination and use of chemicals data may be specified in specific pieces 
of legislation. Today, information on chemicals is already made publicly available by the 
Member  States,  EU  agencies  and  the  Commission.  Various  pieces  of  legislation  (e.g., 
Regulation (EC) 1367/2006 on the application of the provisions of the Aarhus Convention 
on Access to Information, Public Participation in Decision-making and Access to Justice 
in  Environmental  Matters  to Community  institutions  and  bodies  (‘Aarhus  Regulation’); 
Directive (EU) 2019/1024 on open data and the re-use of public sector information (‘Open 
Data  Directive’))  are  in  place  that  ensure  a  high  level  of  transparency  and  data 
dissemination. The Aarhus Regulation, for example, sets as its objective to enable public 
access  to  environmental  information,  which  may  include,  for  example,  chemicals 
monitoring data, either following a request or by active dissemination by the authorities.  

Additional rights on access to documents enshrined in Regulation (EC) No 1049/200127 
and,  where  environmental  information  is  concerned,  the  rights  enshrined  in  Regulation 
(EC)  No  1367/200628  and  Directive  2003/4/EC29  enable  further  routes  of  access  to 
chemicals data, save to data deemed confidential under those legislations.  

The  use  of  chemicals  data  owned  or  generated  by  public  authorities  and  public 
undertakings is already possible today by virtue of a number of pieces of legislation. This 
includes arrangements30 set under the Open Data Directive31, which sets minimum rules 
on the use of data held by the public sector and of publicly  funded research data made 
publicly available through repositories, as well as its Implementing Regulation on high-

27  

28  

29  

30  

31  

Regulation (EC) No 1049/2001 of the European Parliament and of the Council regarding public 
access to European Parliament, Council and Commission documents. OJ L 145, 31.5.2001, p. 43–
48. 
Regulation (EC) No 1367/2006 of the European Parliament and of the Council on the application 
of  the  provisions  of  the  Aarhus  Convention  on  Access  to  Information,  Public  Participation  in 
Decision-making and Access to Justice in Environmental Matters to Community institutions and 
bodies. OJ L 264 25.9.2006, p. 13. 
Directive 2003/4/EC of the European Parliament and of the Council (The Freedom of Access to 
Information). OJ L 41, 14.2.2003, p. 26–32. 
Those arrangements include terms applicable to re-use, formats of data and metadata and technical 
arrangements for dissemination of the public data. 
Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open 
data and the re-use of public sector information. OJ L 172, 26.6.2019, p. 56 – 83. 

29 

 
 
 
value datasets32. In addition, the Data Governance Act33 aims to facilitate the voluntary 
sharing  of  data  by  individuals  and  businesses  and  harmonises  conditions  for  the  use  of 
certain public sector data, without altering material rights on the data or established data 
access and usage rights. Given existing sectoral legislation, with regard to the creation of 
the  Green  Deal  data  space,  the  revision  of  the  INSPIRE  Directive34  will enable  further 
open availability and use of spatial and environmental data. This initiative aims to make it 
easier  for  EU  public  authorities,  businesses  and  citizens  to  support  the  transition  to  a 
greener and carbon-neutral economy and reducing administrative burden. It is expected to 
support reusable data services on a large scale to assist in collecting, sharing, processing 
and analysing large volumes of data relevant for assuring compliance with environmental 
legislation  and  priority  European  Green  Deal  actions.  It  will  streamline  reporting  and 
burden  reduction  through  better  use  of  existing  data,  automatic  reporting  generation 
through data mining and business intelligence.35 

The aim of the legislative initiative at hand is not to change information requirements of 
individual pieces of chemicals legislation, nor is it to change the way in which chemical 
safety assessments are to be conducted. One purpose is however to identify and address 
inefficiencies  in  data  flows  and  obstacles  to  an  effective  chemicals  regulatory 
framework. The following issues and practices under the current regulatory framework 
have been identified: 

•  Besides data collected and generated under EU legislation, data are being held at 
Member State level and not necessarily shared with other Member States or EU 
authorities  or  agencies.  This  is  particularly  the  case  for  monitoring  data  on 
chemicals  in  the  environment.  For  example,  under  Directive  2000/60/EC 
establishing  a  framework  for  the  Community  action  in  the  field  of  water  policy 
(‘Water  Framework  Directive’)  there  is  a  legal  obligation  for  Member  States  to 
report to the Commission when there is an exceedance of environmental quality 
standards. To that end, monitoring activities are carried out in water bodies, but the 
results  of  those  activities  may  never  be  communicated  to  the  EU  level  if  no 
exceedances occur. Yet, such monitoring data can be useful in the context of other 
safety assessments.  

•  An  example  of  an  inefficiency  in  data  collection  obligations  is  the  multiple 
reporting of the same monitoring data of persistent organic pollutants in water as 
part  of  the  implementation  of  Regulation  (EU)  2019/1021  on  persistent  organic 
pollutants  (‘POPs  Regulation),  the  Stockholm  Convention  on  persistent  organic 
pollutants’ effectiveness evaluation and as part of a bigger set of data under the 
implementation  reporting,  Water  Framework 
Water  Framework  Directive 

32  

33  

34  

35  

Commission Implementing Regulation (EU) 2023/138 of 21 December 2022 laying down a list of 
specific high-value datasets and the arrangements for their publication and re-use (Text with EEA 
relevance). OJ L 19, 20.1.2023, p. 43 – 75. 
Regulation  (EU)  2022/868  of  the  European  Parliament  and  of  the  Council  of  30  May  2022  on 
European data governance and amending Regulation (EU) 2018/1724. OJ L 152, 3.6.2022, p. 1–44. 
Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing 
an  Infrastructure  for  Spatial  Information  in  the  European  Community  (INSPIRE).  OJ  L  108, 
25.4.2007, p. 1–14. 
Proposal for a regulation of the European Parliament and of the Council on harmonised rules on fair 
access to and use of data (Data Act). COM (2022) 68 final, explanatory memorandum.  

30 

 
 
 
Directive pollutants prioritisation exercise and the EEA’s State of the Environment 
reporting.  

•  Another issue relates to the management of data and information systems: in case 
of parallel initiatives there is not always sufficient coordination, such as in the 
developments of IPCHEM, Reportnet 2.0 and 3.036 and WISE37. 

•  Monitoring  data  are  often  reported  in  different  formats  with  different  meta-
data structures, which are developed separately from each other for separate data 
collection purposes (e.g. EFSA defines the format for the collection of data in food, 
EEA sets the format for the collection of data for state of the environment reporting 
or  air  monitoring  network  and  the  Commission  prescribes  the  format  for  the 
collection of data under  the Water  Framework Directive prioritisation  exercise). 
OECD harmonised templates OHT 301  – 306  for use and  exposure information 
include the possibility to report certain monitoring information, but the formats do 
not capture individual monitoring data, but their aggregates. The Regulation (EU) 
2019/1381 on the transparency and sustainability of the EU risk assessment in the 
food chain  (‘Transparency Regulation’) empowers the Commission  for the food 
sector to establish standard data formats by means of implementing acts based on 
a proposal  from  EFSA.  There are currently no standard  formats for information 
related to regulatory processes (as disseminated today for a very limited number of 
legislations through ECHA’s public activities coordination tool (PACT)38. 

•  Some monitoring data on chemicals are not appropriately stored, e.g. stored on 

compact discs as part of physical archives. 

•  Today, there is no harmonised identity of chemical substances. Various names 
and  abbreviations  are  used  in  various  systems  and  under  various  pieces  of 
legislation.  

transparency  frameworks,  which  apply 

•  As  regards  data  dissemination  and  transparency,  outside  of  the  generally 
applicable  confidentiality  and 
to 
information held by EU bodies across all legislative frameworks, each regulatory 
regime may introduce its own confidentiality and transparency scheme specifying 
for example which categories of data are always to be made available to the public, 
data which can be claimed confidential and data for which a legal presumption of 
confidentiality is introduced. As an example, the Transparency Regulation obliges 
EFSA  to  disseminate  a  wide  range  of  information.  EFSA  shall  make  publicly 
available all information on which it bases its scientific outputs, where the term 
“scientific  output”  is  subject  to  a  broad  interpretation  and  includes  all  scientific 
opinions,  reports  and  guidelines.  The  possibility  of  data  submitters  to  claim 
confidentiality is limited to a closed list of information and all other information is 
to  be  made  publicly  available.  Regulation  (EC)  1907/2006  concerning  the 
Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH) 
(‘REACH’) and Regulation (EU) 528/2012 concerning the making available on the 
market and use of biocidal products (‘Biocidal Products Regulation’) only foresee 
automatic dissemination by the ECHA for a limited number of specific categories 
of information listed in those Regulations. Other EU bodies either have their own 

36  
37  
38  

Reportnet 2.0 and 3.0.  
Water Information System for Europe (WISE). 
Public Activities Coordination Tool (PACT).  

31 

 
 
 
confidentiality regime (e.g. EMA) or apply only general confidentiality schemes 
(e.g. EEA). 

4.1.2. Academic studies 

For the purposes of this initiative, ‘academic data’ is taken to mean hazard, occurrence and 
exposure data derived from scientific studies published in peer-reviewed literature that 
are not carried out specifically to inform regulatory assessments. Such data are typically 
generated  by  scientists  from  academia  (or  research  organisations)  who  often  use  non-
standard (non-guideline) experimental (animal and non-animal) or computational methods, 
without necessarily complying with any recognised quality system. 

An  assessment  was  made  of  legal  requirements  for  business  operators  to  consider 
academic data in chemical safety assessments for the pieces of EU legislation in scope of 
this  initiative.  A  screening  was  done  for  wordings  and  formulations  that  address  such 
requirements:  “available  data/information/sources/knowledge”;  “academic”;  “scientific 
and technical data”; “scientific data/literature/research”. That screening yielded 11 pieces 
of  legislation  that  include  a  requirement  for  the  uptake  of  academic  data  by  business 
operators  in  their  regulatory  dossiers.  An  overview  of  those  pieces  of  legislation  and 
requirements is given in Table 3. 

Besides legal requirements, many other types of resources have been developed in recent 
years to improve the uptake of academic data for regulatory purposes. An OECD project 
of  the  Working  Party  for  Hazard  Assessment  (WPHA)  was  recently  initiated  on  the 
development of a guidance setting minimum quality and reporting requirements to help 
researchers design, perform and report studies and the development of a search guide for 
finding and retrieving academic data. The project started in 2022 and is foreseen to end by 
2024. 

Table 3 – Overview of pieces of EU legislation with a requirement for industry duty holders to 
consider academic data 
Legislation  

Article and wording  

Regulation (EU) No 
1107/2009 concerning 
the placing of plant 
protection products 
on the market   

Article 8 Dossiers  

 […]  

(5) Scientific peer-reviewed open literature, as determined by the Authority, on 
the  active  substance  and  its  relevant  metabolites  dealing  with  side-effects  on 
health, the environment and non-target species and published within the last 10 
years before the date of submission of the dossier shall be added by the applicant 
to the dossier.   

ANNEX  II  Procedure  and  criteria  for  the  approval  of  active  substances, 
safeners and synergists pursuant to Chapter I  

 [...]  

3.6. Impact on human health  

32 

 
 
3.6.2 An active substance, safener or synergist shall only be approved if, on the 
basis of assessment of higher tier genotoxicity testing carried out in accordance 
with the data requirements for the active substances, safener or synergist and other 
available data and information, including a review of the scientific literature, 
reviewed by the Authority, it is not or has not to be classified, in accordance with 
the provisions of Regulation (EC) No 1272/2008, as mutagen category 1A or 1B.  

[3.6.3,  3.6.4,  3.6.5:  Same  text  for  carcinogenicity,  reproductive  toxicity  and 
endocrine disruption for human health, respectively]   

 3.8.2. […] The identification of an active substance, safener or synergist as 
having endocrine disrupting properties that may cause adverse effect in humans 
in accordance with the fifth paragraph shall be based on all of the following 
points:  
 (1) all available relevant scientific data (in vivo studies or adequately validated 
alternative test systems predictive of adverse effects in humans or animals; as 
well as in vivo, in vitro, or, if applicable, in silico studies informing about 
endocrine modes of action: […]  
 (b) other scientific data selected applying a systematic review methodology, in 
particular following guidance on literature data which is listed in the 
Commission Communications in the framework of setting out the data 
requirements for active substances and plant protection products, in accordance 
with this Regulation;   

ANNEX 
SUBSTANCES  

II 

INFORMATION  REQUIREMENTS  FOR  ACTIVE 

Title 1, Table, 8.13.3. 

 The assessment of endocrine disruption shall comprise the following tiers:   

(a) An assessment of the available information from the following studies and any 
other relevant information, including in vitro and in silico methods: [...]  

(viii)  A  systematic review of  the  literature  including  studies  on mammals  and 
non-mammalian organisms; […]   

Article 5 General provisions on data required for risk assessment 

  […]  
 2. The application dossier shall include all the available data relevant for the 
purpose of the risk assessment (i.e. full published papers of all references cited 
or full copies of the original unpublished studies).  
 […]  
 4. The documentation on the procedure followed when gathering the data shall 
be provided, including the literature search strategies (assumptions made, 
key words used, databases used, time period covered, limitation criteria, 
etc.) and a comprehensive outcome of such search.  

33 

Regulation  (EU)  No 
528/2012  concerning 
the  making  available 
on the market and use 
of biocidal products  

Commission 
Regulation (EU) No 
234/2011 
implementing 
Regulation (EC) No 
1331/2008 establishing 
a common 
authorisation 
procedure for food 
additives, food 
enzymes and food 
flavourings  

 
 
  
Regulation  (EC)  No 
1332/2008  on 
food 
enzymes  

Regulation (EC) No 
1333/2008 on food 
additives  

Regulation (EC) No 
1334/2008 on 
flavourings and 
certain food 
ingredients with 
flavouring properties 
for use in and on 
foods  

Regulation (EC) No 
396/2005 on 
maximum residue 
levels of pesticides in 
or on food and feed of 
plant and animal 
origin  

Commission 
Regulation (EC) No 
429/2008 on detailed 
rules for the 
implementation of 
Regulation (EC) No 
1831/2003 as regards 
the preparation and 
the presentation of 
applications and the 
assessment and the 
authorisation of feed 
additives  

Regulation  (EC)  No 
1223/2009 on cosmetic 
products  

Article 6 General conditions for inclusion of food enzymes in the Community 
list 

 A  food  enzyme  may  be  included  in  the  Community  list  only  if  it  meets  the 
following conditions and, where relevant, other legitimate factors: 

(a)  it  does  not,  on  the  basis  of  the  scientific  evidence  available,  pose  a  safety 
concern to the health of the consumer at the level of use proposed; 

[…] 

(!the  authorisation  procedure  for  being  included  in  list  refers  to  1331/2008,  so 
literature search is implied) 

 Article 14 Information obligation  

1.  A  producer  or  user  of  a  food  additive  [enzyme/flavouring]  shall  inform  the 
Commission  immediately  of  any  new  scientific  or  technical  information  which 
might affect the assessment of the safety of the food additive [enzyme/ flavouring] 
substance.  

Article 7 Requirements relating to applications for MRLs  

1. The applicant shall include in an application for an MRL the following 
particulars and documents:  
 […]  
 (c) a comprehensive overview of relevant concerns raised in the available 
scientific literature about the plant protection product and/or its residue; […]  

ANNEX  II  GENERAL  REQUIREMENTS  TO  BE  SATISFIED  BY  THE 
DOSSIER PROVIDED FOR IN ARTICLE 3  

[…]  
 3.2.2.4.  Chronic  oral  toxicity  studies  (including  carcinogenicity  studies)  
 To investigate the chronic toxic potential and carcinogenic potential, a chronic 
oral toxicity study must be carried out in at least one species, and shall be of at 
least 12 months' duration. The species chosen shall be the most appropriate on the 
basis of all available scientific data, including the results of the 90-day studies.  

 (There are also several references to the use of literature data as proof of evidence; 
yet, it concerns a possibility to use literature data, not an obligation) 

Article 10 Safety assessment  

 1. In order to demonstrate that a cosmetic product complies with Article 3, the 
responsible person shall, prior to placing a cosmetic product on the market, 
ensure that the cosmetic product has undergone a safety assessment on the basis 
of the relevant information and that a cosmetic product safety report is set up in 
accordance with Annex I.  
 The responsible person shall ensure that:  
 […]  

34 

 
 
  
 (b) an appropriate weight-of-evidence approach is used in the safety assessment 
for reviewing data from all existing sources;   

ANNEX 
PRODUCT 
COSMETIC 
 PART A – Cosmetic product safety information  

I 

SAFETY 

REPORT  

Undesirable 

[…]  
effects   
 9. 
 All available data on the undesirable effects and serious undesirable effects to 
the cosmetic product or, where relevant, other cosmetic products. This includes 
statistical data.  

undesirable 

serious 

effects 

and 

REACH  

Article 3 Definitions  

[…]  
 27. full study report: means a complete and comprehensive description of the 
activity performed to generate the information. This covers the complete 
scientific paper as published in the literature describing the study performed 
or the full report prepared by the test house describing the study performed;  

28. robust study summary: means a detailed summary of the objectives, methods, 
results and conclusions of a full study report providing sufficient information to 
make an independent assessment of the study minimising the need to consult the 
full study report;  

29.  study  summary:  means  a  summary  of  the  objectives,  methods,  results  and 
conclusions  of  a  full  study  report  providing  sufficient  information  to  make  an 
assessment of the relevance of the study; […]  

ANNEX  I  GENERAL  PROVISIONS  FOR  ASSESSING  SUBSTANCES 
AND PREPARING CHEMICAL SAFETY REPORTS  

 1.0 Introduction 

1.0.5. For any effect for which no relevant information is available, the relevant 
section  shall  contain  the  sentence:  ‘This  information  is  not  available’.  The 
justification, including reference to any literature search carried out, shall be 
included in the technical dossier. 

 3.0. Introduction 

3.0.3. For any environmental sphere, for which no effect information is available, 
the relevant section of the chemical safety report shall contain the sentence: ‘This 
information  is  not  available’.  The  justification,  including  reference  to  any 
literature research carried out, shall be included in the technical dossier. […] 

3.1. Step 1: Evaluation of information  
 3.1.1. The evaluation of all available information shall comprise:   
 […]  
 — the hazard identification based on all available information,  

35 

 
 
  
 
 […] 

5.1. Step1: Development of exposure scenarios 

5.1.1. Exposure scenarios as described in Sections 0.7 and 0.8 shall be generated. 
Exposure  scenarios  are  the  core  of  the  process  to  carry  out  a  chemical  safety 
assessment.  The  chemical safety  assessment  process may  be  iterative.  The  first 
assessment  will  be  based  on  the  required  minimum  and  all  available  hazard 
information  and  on  the  exposure  estimation  that  corresponds  to  the  initial 
assumptions  about  the  operating conditions  and  risk management measures (an 
initial exposure scenario). 

ANNEX  II  REQUIREMENTS  FOR  THE  COMPLETION  OF  SAFETY 
DATA SHEETS 

 9.1. Information on basic physical and chemical properties 

[…] 

(c) Odour - A qualitative description of the odour shall be given if it is wellknown 
or described in the literature. 

16. SECTION 16: Other information  

This  section  of  the  safety  data  sheet  shall  contain  other  information  that  is  not 
included in sections 1 to 15, including information on the revision of the safety 
data sheet such as: 

[…] 

(c) key literature references and sources for data;  

ANNEX  VI  INFORMATION  REQUIREMENTS  REFERRED  TO  IN 
ARTICLE 10 

 […] 

STEP 1 – GATHERING AND SHARING EXISTING INFORMATION 

The registrant should gather all existing available test data on the substance to be 
registered, this would include a literature search for relevant information on 
the substance. 

Wherever  practicable,  registrations  should  be  submitted  jointly,  in  accordance 
with Articles 11 or 19. This will enable test data to be shared, thereby avoiding 
unnecessary testing and reducing costs. The registrant should also collect all other 
available and relevant information on the substance including on all nanoforms of 
the substance that are covered by the registration, regardless whether testing for a 
given endpoint is required or not at the specific tonnage level. This should include 
information from alternative sources (e.g. from (Q)SARs, read-across from other 

36 

 
 
  
   
substances, in vivo and in vitro testing, epidemiological data) which may assist in 
identifying the presence or absence of hazardous properties of the substance and 
which  can  in  certain  cases  replace  the  results  of  animal  tests.  In  addition, 
information on exposure, use and risk management measures in accordance with 
article  10  and  this  Annex  should  be  collected.  Considering  all  this  information 
together,  the  registrant  will  be  able  to  determine  the  need  to  generate  further 
information. 

ANNEX  VII  STANDARD  INFORMATION  REQUIREMENTS  FOR 
SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 
ONE TONNE OR MORE 

 […] 

Before new tests are carried out to determine the properties listed in this Annex, 
all  available  in vitro  data,  in  vivo  data,  historical  human  data,  data  from  valid 
(Q)SARs  and  data  from  structurally  related  substances  (read-across  approach) 
shall be assessed first. 

(same wording in Annex VIII, IX, X) 

ANNEX  XIII  CRITERIA  FOR  THE 
IDENTIFICATION  OF 
PERSISNTENT,  BIOACCUMULATIVE  AND  TOXIC  SUBSTANCES, 
AND  VERY  PERSISTENT  AND  VERY  BIOACCUMULATIVE 
SUBSTANCES 

 […] 

A  weight-of-evidence  determination  means  that  all  available  information 
bearing on the identification of a PBT or a vPvB substance is considered together, 
such as the results of monitoring and modelling, suitable in vitro tests, relevant 
animal data, information from the application of the category approach (grouping, 
readacross), (Q)SAR results, human experience such as occupational data and data 
from  accident  databases,  epidemiological  and  clinical  studies  and  well 
documented case reports and observations. The quality and consistency of the 
data shall be  given appropriate weight. The available results regardless of their 
individual conclusions shall be assembled together in a single weight-of-evidence 
determination. 

Regulation (EC) No 
1272/2008 on 
classification, 
labelling and 
packaging of 
substances and 
mixtures 

Article  5  Identification  and  examination  of  available  information  on 
substances  

 1. Manufacturers, importers and downstream users of a substance shall identify 
the  relevant  available  information  for  the  purposes  of  determining  whether  the 
substance entails a physical, health or environ mental hazard as set out in Annex 
I, and, in particular, the following:  

[…]  

(d) any new scientific information;  

37 

 
 
   
(e)  any  other  information  generated  under  internationally  recognised  chemical 
programmes.  

4.1.3. Data generation mechanisms 

A  few  regulatory  processes  and  other  initiatives  exist  today  to  obtain  or  generate 
(additional) data, from industry duty holders, through EU agencies or national authorities 
or via the research community.  

Transparency Regulation – verification tool  

Regulation  (EU)  2019/1381  on  the  transparency  and  sustainability  of  the  EU  risk 
assessment  in  the  food  chain  (‘Transparency  Regulation’)  amends  Regulation  (EC) 
178/2002 laying down the general principles and requirements of food law (‘General Food 
Law’) and establishes a verification tool (Article 32d of the General Food Law) allowing 
the  Commission  –  in  exceptional  circumstances  of  serious  controversies  or  conflicting 
results  –  to  mandate  the  EFSA  to  commission  additional  studies  with  the  objective  of 
verifying evidence used in the context of risk assessment. The studies commissioned may 
have a wider scope than the evidence subject to verification, for example, in cases where 
new scientific developments become available. The verification tool is financed by the EU 
budget. An annual  budget  is  foreseen of EUR  24-40 million for grant  and procurement 
activities. This budget is used for verification studies (at the date of writing of this Staff 
Working Document no verification study has been commissioned) but also for activities 
related  to  EFSA’s  obligations  under  Article  32  of  the  General  Food  Law  (scientific 
studies). 

General Food Law – scientific studies 

Pursuant  to  Article  32  of  the  General  Food  Law,  EFSA,  using  the  best  independent 
scientific  resources  available,  has  the  obligation  to  commission  scientific  studies 
necessary for the performance of its mission. Such studies shall be commissioned in an 
open and transparent fashion and EFSA shall seek to avoid duplication with Member State 
or  Community  research  programmes  and  shall  foster  cooperation  through  appropriate 
coordination.  

EFSA  implements  this  by  regular  commissioning  of  scientific  studies  managed  by  the 
Science Studies and Project Identification and Development Office (SPIDO). The goals of 
these projects are to:  

•  enhance  EFSA’s  capacity  to  identify  studies  or  projects  benefitting 

regulatory processes and science  
fill knowledge gaps to ensure preparedness for: 

• 

o  possible divergences on sensitive matters (‘verification’ studies)  
o  future  risk  assessment  requirements  due  to  evolving  scientific 

knowledge and legislation  

•  enhance capacity building and build partnerships  

38 

 
 
 
 
No specific budget is foreseen for the EFSA for these activities. In practice, the budget 
allocated to the EFSA for verification studies is used for the conduct of scientific studies 
in the absence of any need of or request for a verification study. 

REACH Regulation - substance evaluation 

Regulation (EC) 1907/2006 on Registration, Evaluation, Authorisation and Restriction of 
Chemicals (‘REACH’) regulates the manufacture and use of chemical substances, aiming 
to ensure a high level of protection of human health and the environment. Under REACH, 
it  is  generally  expected  that  necessary  and  adequate  hazard  data  is  compiled  (and  as 
necessary generated) following standard information requirements for the registration of 
chemicals. A completeness check and compliance check ensure that such information is 
indeed submitted in a registration dossier.  

Under the substance evaluation process, the evaluating Member State has the possibility 
to request ECHA to issue a decision requiring the registrant(s) of a substance to provide 
further information to verify/clarify a specific risk-based concern. This request of the MS 
takes the form of a draft decision submitted to and adopted by the ECHA’s Member State 
Committee.  The  information  that  may  be  requested  in  the  decision  may  go  beyond  the 
standard  information  requirements  of  REACH.  For  example,  registrants  may  need  to 
provide  studies  specific  to  mode  of  action,  endocrine  disruption  properties,  higher  tier 
hazard information even if all registrants have registered at lower tonnages, or monitoring 
of concentration levels in organisms or the environment. The registrant has to submit the 
information required to ECHA by the deadline set. 

Water Framework Directive – watch list 

Directive 2013/39/EU as regards priority substances in the field of water policy requires 
the Commission to establish a watch list of substances for which EU-wide monitoring 
data is to be gathered, based on which the risk of the substances can be determined and 
a conclusion can be drawn as to whether Environmental Quality Standards (EQS) should 
be set for them at EU level.  A specific procedure is laid down in Directive 2013/39/EU to 
add substances to the surface water watch list. The number of substances that can be added 
at each update of the watch list depends on how many substances are deleted from it, as 
the  length  of  the  watch  list  is  currently  restricted  to  13  substances.  Member  States  are 
obliged to monitor the substances on the surface water watch list at least once a year and 
report their data annually. The watch list is reviewed every two years and substances can 
be on the list for up to four years. When enough reliable monitoring data on a substance 
has been gathered to conduct a risk assessment, this substance is removed from the watch 
list. If a risk has been identified, the substance will become a candidate for designation as 
a priority substance under Directive 2000/60/EC establishing a framework for Community 
action in the field of water policy (‘Water Framework Directive’, entailing the derivation 
or refinement of an EQS. 

A similar watch list approach for groundwater was introduced in Directive 2006/118/EC 
on  the  protection  of  groundwater  against  pollution  and  deterioration  (‘Groundwater 
Directive’).  However,  monitoring  of  the  substances  on  the  groundwater  watch  list  is 
voluntary, which leads to an incomplete picture of the situation.  

39 

 
 
The  Water  Framework  Directive  and  its  daughter  directives  mentioned  above  were 
recently reviewed and a proposal39 for amending the directives was published. Regarding 
the watch list systems, the main proposed changes are making monitoring of the substances 
on  the  groundwater  watch  list  mandatory  for  the  MS  and  streamlining  the  process  of 
reviewing monitoring data and updating the watch lists.  

Land Use and Coverage/Area frame Survey (LUCAS) - soil survey 

LUCAS is an in-situ survey designed to provide harmonized statistics on land cover and 
land use across the EU. The LUCAS campaign in 2022 observed 400,000 point locations 
in the EU, half of them in the field while and the other half through photointerpretation. 
The LUCAS 2022 soil survey was carried out at a subset of 41,000 locations for which 
topsoil  samples  were  collected  and  analysed  for  (standard)  physical  and  chemical 
parameters. The results give a general overview of the soil characteristics, and give insight 
in soil health and e.g., resilience of the soil related to chemical risk assessment. Also, the 
socio-economic  land  use  might  be  useful  to  give  an  indication  of  vulnerability  of  the 
location  and  the  activities  carried  out  (residential,  public  space,  …)  in  relation  to  the 
potential impact of chemical accidents. 

The results of the LUCAS soil survey support policy needs of a variety of EU policies like 
the Soil Strategy for 2030, the Common Agricultural Policy, the EU Farm2Fork strategy, 
the  Circular  Economy  Action  Plan,  Climate  Law,  and  EU  policies  in  the  area  of 
biodiversity and land degradation neutrality, the sustainable development goals, Europe in 
a wider world and the Green Agenda for the Western Balkans40. 

Before a new soil survey campaign is undertaken, the Joint Research Centre assesses the 
different policy needs and adapts the data to be gathered in the surveys accordingly, e.g., 
if new parameters are needed. Data generation under the LUCAS soil survey is recurrent. 
It is not linked to a specific legislation but the results contribute to multiple policy needs 
of a variety of EU policies. LUCAS soil is funded from the EU budget and is performed 
under the surveillance of ESTAT and the JRC.  

H2020, Horizon Europe and co-funded European partnerships  

Several projects funded under the European Union’s Horizon Europe framework have led 
to the generation of information that may be relevant in a Union chemicals regulatory or 
policy context. For example, the European Human Biomonitoring Initiative (HBM4EU41- 
a  joint  European  human  biomonitoring  (HBM)  initiative  running  from  2017  to  2022, 
collected  existing  as  well  as  new  human  biomonitoring  datasets  and  harmonised  data 
collection  and  management  approaches.  Other  examples  are  EU-funded  H2020  and 

39  

40  

41  

Proposal  for  a  directive  of  the  European  Parliament  and  of  the  Council  amending  Directive 
2000/60/EC establishing a framework for Community action in the field of water policy, Directive 
2006/118/EC on the protection of groundwater against pollution and deterioration and Directive 
2008/105/EC  on  environmental  quality  standards  in  the  field  of  water  policy.  COM  (2022)  540 
final.  
Jones, A., Fernandes-Ugalde, O., Scarpa, S. & Eiselt, B. (2021) LUCAS 2022, EUR 30331 EN, 
Publications  Office  of  the  European  Union,  Luxembourg.,  2021,  ISBN  978-92-76-21079-5, 
doi:10.2760/74624, JRC121253, pp. 46. 
https://cordis.europa.eu/project/id/733032  

40 

 
 
 
Horizon  Europe  projects  coordinated  in  clusters  of  projects  (e.g.  NanoSafety  Cluster42, 
CUSP Cluster43 and IDEAL Cluster44, which share a common theme of improving tools, 
skills and knowledge.  

The  co-funded  public-public  Partnership  for  the  Assessment  of  Risks  from  Chemicals 
(PARC)45 (in which the EU together with public partners commit to jointly support the 
development and implementation of a programme of research and innovation activities that 
significantly contributes to achieving EU policy priorities) was selected for funding for the 
2022-2029 period.  

These  large  EU-funded  research  initiatives  help  support  the  implementation  of  the 
European  Union's  Chemicals  Strategy  for  Sustainability,  paving  the  way  for  the  "zero 
pollution" ambition announced in the European Green Deal.  

EUON – European Union Observatory for nanomaterials  

While  having  a  very  specific  setting  and  scope,  in  its  core,  the  European  Union 
Observatory  for  nanomaterials  is  a  data  generation  (and  dissemination)  mechanism, 
dedicated  at  present  to  nanomaterials,  a  subclass  of  chemicals  considered  at  times  to 
warrant  an  additional  survey  to  support  the  development  and  implementation  of  and 
confidence in chemicals policies when addressing the innovative and rapidly evolving field 
of  nanotechnology,  introducing  new  materials  on  which  general  knowledge  and 
understanding and appreciation of potential risks may not have been sufficiently informed 
through the standard reporting channels.  

As first-generation (passive) nanomaterials are getting increasingly mainstreamed also in 
reporting e.g. following implementation of nano-specific provisions in product legislation 
(food  law,  cosmetics,  medical  devices,  biocidal  products)  and  through  an  update  of 
REACH  registration  obligations  with  nanoform-specific  requirements  in  2018,  further 
generation of active nanomaterials is slowly entering the market, alongside other classes 
of complex materials dubbed ‘advanced’ due to their rational design of structural features, 
often at nanoscale, that bring new and enhanced properties. The present approach by the 
Observatory to search the market for available information and launch dedicated studies 
on  particular  aspects  on  properties,  presence  and  use  of  nanomaterials  can  be  naturally 
extended with innovation.  

4.1.4. Notification of studies 

Transparency Regulation – notification of studies 

The Transparency Regulation lays down rules for the food sector on the transparency and 
sustainability of the EU risk assessment in the food chain. The Transparency Regulation 

42  
43  

44   
45  

EU NanoSafety Cluster – The NanoSafety Community 
CUSP cluster - The European Research Cluster to Understand the Health Impacts of Micro- and 
Nanoplastics (cusp-research.eu) 
Home - IDEAL CLUSTER 
https://cordis.europa.eu/project/id/101057014  

41 

 
 
 
introduces  a  study  notification  mechanism  in  Article  32b  and  in  Article  32(c)(1)  in  the 
General Food Law. 

The  purpose  of  the  notification  provision  is  to  ensure  that  all  relevant  available  data  is 
taken  into  account  in  a  regulatory  dossier  (an  application  or  notification  dossier  in  this 
case). To that end, all studies that are being commissioned or carried out in the context of 
the  preparation  of  an  application  or  notification  are  to  be  notified.  The  following 
information needs to be notified: title of study, scope of study, study type, study design, 
actual or planned start date, completion date, business operator, and lab or testing facility. 

An application or notification which is supported by studies that have not been previously 
notified  in  accordance  with  the  Regulation  will  not  be  considered  valid  or  admissible 
unless a valid justification is provided for the non-notification of the study. Likewise, an 
application  which  is  not  supported  by  studies  that  have  been  previously  notified  in 
accordance with the Transparency Regulation will not be considered valid or admissible, 
unless a valid justification is provided for the non-inclusion of the study in the application 
dossier.  In  case  the  justification  provided  is  considered  invalid,  the  applicant  will  be 
requested to submit any missing data relating to any supporting studies.  In addition, a six 
months standstill will be applied before the newly submitted application or notification is 
assessed.  

Information  on  notified  studies  is  stored  in  a  database  hosted  by  EFSA.  The  notified 
information will be made public only in cases where a corresponding valid application was 
submitted to EFSA. EFSA publishes the extract of the relevant studies from the database 
at the moment the validity of the application is confirmed. Prior to doing that, the applicant 
gets the opportunity to claim possible data confidential.  

REACH – testing proposals 

REACH does not create advance notification obligations for those who are generating data 
that may eventually be used in registration. However, if information required according to 
Annex IX or X to REACH is not available and needs to be generated by a registrant, the 
registrant needs to submit a testing proposal to the ECHA. The purpose of the notification 
mechanism for testing proposals is to avoid unnecessary testing in general on vertebrate 
animals (through a public consultation organised by the ECHA on the testing proposal), to 
ensure that proposed tests meet real information needs, to ensure that the best use has been 
made  of  existing  information  and  that  the  most  adequate  test  is  performed  to  fulfil 
information requirements for risk assessment and hazard classification.  

After the public consultation period, the ECHA examines the testing proposal and adopts 
a decision. In the decision, ECHA can either require the registrant to carry out the proposed 
test  as  set  out  in  the  testing  proposal  or  modify  the  testing  conditions  and/or  impose 
additional  requirements.  ECHA  may  also  decide  to  reject  the  testing  proposal  or  set  a 
deadline to perform and provide the test results. 

Directive on the protection of animals – notification of studies 

Directive 2010/63/EU on the protection of animals used for scientific purposes includes 
provisions on the evaluation and authorisation of projects involving the use of animals. 

42 

 
 
The  purpose  of  those  provisions  is  to  protect  animals  from  being  used  for  scientific 
purposes. 

To  start  a  scientific  project  using  living  animals,  an  application  must  be  submitted  and 
authorisation received. Information to be notified includes at least (a) the project proposal; 
(b) a non-technical project summary; and (c) information on the elements set out in Annex 
VI of the Directive, which include the relevance and justification of use of animals and 
procedures,  application  of  methods  to  replace,  reduce  and  refine  the  use  of  animals  in 
procedures, and competence of people included in the project.  

In practice, applications are not submitted for single, separate well defined studies, but a 
‘project’ is taken to cover all activities in the course of a period of ca. five years and making 
use of living animals. 

Directive on good clinical practice – notification of studies 

Directive  2001/20/EC  relating  to  the  implementation  of  good  clinical  practice  in  the 
context of clinical trials  on medicinal products for human use stipulates principles with 
regard to performing clinical trials on medicinal products for human use. The Directive 
discusses a notification mechanism in Articles 8, 9 and 10. 

The  purpose  of  the  notification  provision  is  to  collect  and  assess  applications  from 
organisations  that  seek  approval  for  the  commencement  of  a  clinical  trial.  These 
organisations are referred to as sponsors and could be individuals, companies, institutions 
or other organisations which take the responsibility for the initiation, management and/or 
financing  of  a  clinical  trial.  They  are  obliged  to  notify  the  competent  authority.  Only 
approved requests for authorisation allow sponsors to conduct a clinical trial. 

Information to be notified includes the following: 

•  Trial identification information 

• 

Identification of the sponsor responsible for the request 

•  Applicant identification information 

• 

Information on each investigational medicinal product (IMP) 

•  General information on the trial 

•  Population of trial subjects 

•  Clinical trial sites/investigators in the Member State concerned by the request 

•  Competent  authority/ethics  committee  in  the  Member  State  concerned  by  the 

request 

•  Signature of the applicant in the Member State 

The sponsor may only start a clinical trial if the competent authority in the Member State 
concerned did not see any grounds for non-acceptance, and once the ethics committee has 
issued a favourable opinion on the application.  

Good laboratory practice 

43 

 
 
Good  laboratory  practice  (GLP)  is  a  quality  system  concerned  with  the  organisational 
process  and  the  conditions  under  which  non-clinical  health  and  environmental  safety 
studies are planned, performed, monitored, recorded, archived and reported. Its purpose is 
to  ensure the quality  and integrity of the safety  data submitted to  regulatory authorities 
('GLP receiving authorities'). The principles of GLP are applied to the non-clinical safety 
testing of test items contained in a range of products. The application of GLP is required 
by a variety of different product-specific legislation.  

Directive  2004/10/EC  on  the  harmonisation  of  laws,  regulations  and  administrative 
provisions relating to the application of the principles of good laboratory practice and the 
verification of their applications for tests on chemical substances is one of the two core 
Union  GLP  Directives  together  with  Directive  2004/9/EC  on  the  inspection  and 
verification of good laboratory practice (GLP). 

4.1.5. Identification of emerging chemical risks 

Several initiatives exist in the EU aiming at the identification of potential environmental 
and health risks of chemicals in use in the EU.   

EFSA emerging risks exchange network (EREN) 

EREN serves  to  facilitate the exchange of information  between  the  EFSA and Member 
States on potential emerging risks relating to food and feed safety, including for animal 
health.  During  regular  meetings,  the  EREN  members  work  out  an  expert  opinion  on 
emerging  issues,  in  specific  areas  of  interest  for  the  EFSA,  covering  also  emerging 
chemicals in the food/feed chain and drivers of and interactions with emerging biological 
risks. The EREN also discusses and proposes follow-up actions for the EFSA.  

Norman Network  

The  NORMAN  network  enhances  the  exchange  of  information  on  substances  posing  a 
potential  risk  to  the  environment  and  encourages  the  validation  and  harmonisation  of 
common  measurement  methods  and  monitoring  tools  so  that  the  requirements  of  risk 
assessors and risk managers can be better met. It specifically seeks both to promote and to 
benefit from the synergies between research teams from different countries in the field of 
emerging substances.  

Horizon Europe and co-funded European partnership 

The  co-funded  public-public  European  Partnership  for  the  Assessment  of  Risks  from 
Chemicals (PARC)46 aims to develop a scientific and technical basis for an early warning 
system  on  chemical  risks.  The  work  involves  the  development  and  validation  of  early 
warning monitoring tools for humans, the environment and products combining exposure 
and  hazard  data  as  well  as  machine  learning  for  patterns  to  identify  new  hazardous 
substances,  their  sources  and  transformation  products.  The  substances  from  the  early 

46  

 European Partnership for Risk of Chemicals (PARC). 

44 

 
 
 
warning  tools  and  framework  are  ranked  based  on  their  potential  risks  and  integrative 
models and are made publicly available. 

The  Horizon  Europe  cluster  of  projects  CUSP47,  aims  at  understanding  the  complex 
relationships between exposure to micro- and nano plastics and human health. The cluster 
works on the development of methodologies for risk assessment that consider the whole 
life cycle of chemicals and develops risk evaluation frameworks tailored to the different 
sources, fate, exposure route and scenarios, hazardous effects and risk indicators for micro- 
and nano plastics. 

4.2. 

 Description of how problems can be addressed 

4.2.1. Addressing the problem that chemicals data is scattered and some information 
flows are suboptimal 

In order to bring together chemicals data, the only viable and effective option identified 
was the establishment of an IT infrastructure, serving  as a  central  platform  from  where 
such  information  can  be  accessed  as  interoperable  data  and  supported  by  data  services 
facilitating use cases such as chemical assessments by authorities. Such a common data 
platform on chemicals (CDPC) is foreseen to be established by the ECHA. Complementary 
to the establishment of the platform, and in order to increase efficiency and coherence, a 
number of information flows was considered for redirection.  

Establishment of common data platform on chemicals 

The feasibility and added value of establishing an EU common data platform on chemicals 
have been evaluated by a comprehensive “Feasibility study on a common open platform 
on chemical safety data”48, supported by the European Parliament.  

The study, while framed from the beginning on a single premise of establishing a new IT 
platform on chemicals, has cast its analysis very widely to ensure the appreciation of the 
extent of the problem and opportunities such platform is aiming to address. It analysed the 
baseline (no action) vs.  the added value of different  ways to  establish and populate the 
platform,  and  estimated  resources  required  to  develop  and  govern  it.  Seventy  existing 
information systems were analysed/screened and 100 stakeholders from different groups 
were interviewed for, or contributed to, the analysis. Details of the analysis are available 
in the final study report and summarized well in an executive summary.  

Even with the expected evolution in IT services and availability of chemicals data in digital 
form,  there  is  no  existing  platform  that  addresses  (or  would  be  able  to  address  with 
minimal  effort)  the stated objectives. A one-off solution  merging  current  datasets  also 
does  not  make  much  sense  from  an  efficiency  or  sustained  usefulness  perspective.  The 
only meaningful solution is a platform dynamic in terms of content and services provided, 

47  

48  

CUSP  cluster  -  The  European  Research  Cluster  to  Understand  the  Health  Impacts  of  Micro-  and 
Nanoplastics (cusp-research.eu) 

European Commission, Directorate-General for Environment, Feasibility study on a common open 
platform on chemical safety data, Publications Office of the European Union, 2022. 

45 

 
 
 
establishing rules and controlled vocabularies for repeated ingestion of data, responding in 
time to the use cases supported, and opportunities with regard to individual datasets which 
may require changes either to their formats or sharing and use conditions, before they can 
be efficiently integrated.  

Such a platform should from the onset be designed as an integral part of the EU Green 
Deal Data Space49 and exploit work done on IT building blocks from existing platforms 
and  formats  (e.g.  IUCLID).  There  are  different  technical  solutions  available  for  the  IT 
infrastructure  behind  the  platform:  options  rotate  mainly  around  different  ways  of 
addressing data infrastructure (consolidated or federated models), security (ability to form 
secure  enclaves), and functionalities (basic vs. advanced such  as  analytics  and insights, 
interface support). Considering extensions are always an option but may come at the cost 
of  inefficiency  and  time,  four  different  possibilities  were  evaluated,  providing 
recommendation for a stronger, flexible  architecture with full support to federated access 
but enabling local database service solution as well, and a list of initial functionalities to 
be supported in a minimum viable product.  

The study was used as a basis for further elaboration of a technical implementation plan 
including the delineation of tasks, governance and resource estimates for setting up such a 
platform by the Commission services and the agencies50. It was prepared by a dedicated 
subgroup  of  the  inter-service  group  on  one  substance,  one  assessment  and  driven  by  a 
working vision: 

The platform aims to become a sustainable, single access point for chemicals related data 
and  information  at  EU  level.  It  should  facilitate  the  sharing,  access,  re-use  and 
dissemination of information on chemicals and allow for, e.g., improvement of quality 
and coherence of chemical assessments, identification of chemicals of concern, grouping 
of  chemicals  based  on  inherent  properties,  identification  of  candidates/ideas  for 
enforcement campaigns and the search for substitutes. This IT infrastructure, set as an 
integral  element  of  the  European  Green  Deal  Data  Space,  is  expected  to  be  a  key 
technical  enabler  for  access  to  data  and  information  on  planned  and  concluded 
regulatory actions related to chemicals across the different EU legislative regimes.  

The platform is expected to serve the widest possible community, with robust governance 
and providing reliable service and with the ability to evolve, addressing new use cases and 
stakeholder  expectations,  ingesting  new  relevant  datasets,  develop  functionalities  and 
respond to its developing ecosystem of tools and applications.   

ECHA  has  been  identified  as  the  appropriate  agency  designated  to  establish  and 
manage the platform, apply a governance scheme that is prepared and adopted with 
other  EU  agencies  and  the  Commission,  and  actively  seek  input  from  other 
stakeholder/users of the platform to maximize its utility.  ECHA is thus responsible for 

49  
50  

Green Deal Dataspace.  
The Project Initiation Document will represent part of the Staff Working Document in support of 
the legal proposal. It already includes consideration of technical solutions regarding architecture, 
governance scheme, tasks for ECHA as the manager of the platform as well as expected tasks for 
the agencies, serving as data providers responsible to prepare individual identified datasets ready 
for ingestion in the platform within the timeline set as part of the initial “minimum viable product”.  

46 

 
 
 
‘the container’, the technical implementation of the IT infrastructure set to provide access 
to the information, and coordination of the necessary common work established through 
governance (e.g. agreements on interoperability).  

The information (i.e. content) is brought to ECHA by data providers. It is expected that 
data providers themselves make the effort to ensure the data is ready for ingestion in the 
platform i.e. follows the appropriate format, respects agreed controlled vocabularies and 
includes the necessary context information to make integration possible.  

With further consideration on practical implementability and governance, and the datasets 
identified in the supporting study for a minimum viable product, it is considered that the 
scope of data providers should, at least in the initial implementation, be limited only to the 
Commission and the EU agencies; an obligation established for these actors can ensure 
that the information they hold is prepared for ingestion and sent to ECHA to introduce in 
the platform (ECHA has the same obligation on its own datasets). This obligation directly 
applies  to  main  datasets  compiled  or  generated  as  part  of  their  legal  obligations,  e.g. 
REACH  registration  or  information  on  regulatory  processes  and  substance-specific 
activities. Future data such as information generated through a data generation mechanism 
(see section 4.1.3) or new datasets with chemicals data established as part of any potential 
further  legal  obligations  would  automatically  fall  under  such  obligation.  As  with  other 
datasets that might be agreed for the inclusion in the platform, ingestion in the platform 
would be a planned activity covered in its implementation plan.  

In addition, at the request of the Commission, the data providers would be expected to host 
and  maintain  -  and  correspondingly  provide  to  the  platform  -  also  further  data 
corresponding to their mandate and the type of data they already hold, e.g.  the EEA would 
cover occurrence data for the environment and human biomonitoring data (see also section 
4.2.1).  

The  scheme  indicated  does  not  exclude  the  possibility  to  include  further  datasets,  for 
example  specific  datasets  prepared  at  national  level  or  international  organisation.  The 
approach  however  includes  an  agreement  in  accordance  with  the  procedure  set  in  the 
governance  scheme  and  its  inclusion  in  the  implementation  plan.  The  responsible  to 
prepare the dataset for ingestion and to coordinate with ECHA will however always remain 
one of the EU agencies or the Commission, becoming ‘a patron’ by establishing a dataflow 
from the original data owner based on the type of data to be included (e.g. ECHA typically 
on hazard data, EEA typically on occurrence data, EFSA on food-related data etc.).  

The content as well as functionalities of the existing Information Platform for Chemical 
Monitoring  (IPCHEM)  are  to  be  integrated  into  the  EU-CDPC  in  a  phased  manner  to 
prevent any disruption to its current function. 

Information compiled from different sources may include confidential data and may have 
specific conditions of use. The platform will ensure that context information will allow 
the identification of the data’s origin, will allow differentiated access (Commission, EU 
agencies and competent authorities vs. general public), will apply the originator principle 
to the content available in the platform, and will describe conditions under which use of 
the data by the Commission, EU agencies and competent authorities is allowed.  

47 

 
 
A list of functionalities was developed in the feasibility study51 considered appropriate to 
inform the initial development and estimates of resources required. Standard data services 
(search etc.) are already well covered by standard features of IT building blocks expected 
to be applied. Whether they will be effective is however very dependent on the application 
of controlled vocabularies (in particular relating to substance identity) to the datasets in the 
platform.  Developing  rules  and  vocabularies  and  the  preparation  of  the  datasets  before 
ingestion  by  the  data  providers  are  considered  critical  parts  of  the  task  but  cannot  be 
specified in detail in the legal text. There are however some clear dedicated products, 
tools/functionalities  underpinned  by  specific  curated  data  that  will  exist  only  in  the 
platform and have been identified in advance as required to support the overarching one 
substance, one assessment use case. Their sustained availability needs to be ensured by 
specific  listing,  as  they are  not  covered  by  other  legal  instruments.  Some  precursors  of 
these products may already exist: 

1.  Repository of reference values  

ECHA will be expected to maintain a repository with reference values and relevant 
metadata  information.  While  EU  agencies  (ECHA,  EFSA,  EMA,  EU-OSHA) 
would be expected to provide ECHA any derived reference value, additional work 
and  curation  are  also  considered  to  ensure  continuous  updated  availability  of 
further  selection  of  reference  values  established  via  national  activities  or 
international  organisations.  Within  the  platform,  the  repository  may  become 
associated with the chemicals legislation finder (see below).  

2.  Database of notified studies  

Based on the information generated through established legal provisions under the 
Transparency  Regulation,  the  ECHA  will  compile  potential  new  notification 
information  (see  section  4.2.6)  and  make  it  available  within  the  platform  in 
accordance with the relevant conditions of dissemination and use.  

3.  Information  on  regulatory  processes  ECHA  shall  manage  a  database  with 
information on regulatory processes related to chemical safety assessments as well 
as substance-specific activities that are planned, ongoing or completed by Member 
States,  Union  institutions  or  agencies.  While  the  obligation  to  share  this 
information in the platform between the agencies is already established by default, 
the provision sets a specific obligation on ECHA to compile this information and 
provide dedicated functionalities supporting effective exchange and coordination, 
when appropriate. 

4.  Information on the obligations under EU acts on chemicals  

ECHA is presently already providing  information on regulatory processes on its 
dissemination platform through the EU Chemicals Legislation Finder52, supporting 

51  

52  

Feasibility study on a common open platform on chemical safety data - Publications Office of the EU 
(europa.eu) 

EU Chemicals Legislation Finder (EUCLEF).  

48 

 
 
 
any  user  in  identifying  all  legal  provisions  applicable  to  a  specific  chemical 
substance. Introducing it as a dedicated product under the common data platform 
will establish its availability as ECHA’s legal obligation, while at the same time 
push  its  integration  with  other  information  available  in  the  platform  for  further 
added value. 

5.  Database on environmental sustainability related information 

Recognised  as  an  upcoming  need  based  on  ongoing  initiatives53,  a  database  on 
environmental  sustainability  related  information,  including  data  on  resources, 
emissions and relevant by-products of a chemical, will be included in the platform. 
The ECHA should establish that database, collect relevant data as made available 
by  the  Commission,  the  Agencies  and,  where  relevant,  by  the  researchers  and 
research  consortia  funded  by  Union  framework  programmes,  and  integrate  the 
content of that database into the common data platform as a dedicated service. 

6.   Repository of standard formats and controlled vocabularies 

including  work  with 

Setting  standard  formats  and  controlled  vocabularies  is  an  extensive  exercise 
spanning  across  different  activities, 
international 
organisations, and is supported by different agencies, covering very different types 
of chemicals data with different solutions employed. At the same time, it is pivotal 
work supporting the integration of information in the platform itself and therefore 
a crucial task under its governance. Organised access to this standardisation work 
on the platform directly serves platform data providers, facilitates one substance, 
one  assessment  actions  on  harmonisation  of  data  and  methods  between  the  EU 
chemical assessors, and serves the wider chemical community. The scope is to be 
understood in the wider sense and includes for example the preparation of a curated 
set of substance names and identifiers used to support integration in the platform. 

Redirection of information flows 

53  

Proposal for a regulation of the European Parliament and of the Council establishing a framework 
for setting ecodesign requirements for sustainable products and repealing Directive 2009/125/EC 
(Ecodesign  Regulation)  (COM  (2022)  142  final.);  Directive  (EU)  2022/2464  of  the  European 
Parliament  and  of  the  Council  of  14  December  2022  amending  Regulation  (EU)  No  537/2014, 
Directive  2004/109/EC,  Directive  2006/43/EC,  and  Directive    2013/34/EU  as  regards  corporate 
sustainability reporting (Corporate Sustainable Reporting Directive) (OJ L 322, 16.12.2022, p. 15 
–  80.);  Proposal  for  a  directive  of  the  European  Parliament  and  of  the  Council  on  corporate 
sustainability due diligence and amending Directive (EU) 2019/1937 (Corporate Social Responsible 
Directive)  (COM  (2022)  71  final.);  The  Commission  Recommendation  of  8  December  2022 
establishing a European assessment framework for ‘safe and sustainable by design’ chemicals and 
materials  (C  (2022)  8854  final.);  The  Commission  Recommendation  on  the  use  of  the 
Environmental  Footprint  methods  to  measure  and  communicate  the  life  cycle  environmental 
performance of products and organisations (C (2021) 9332 final.); and Regulation (EU) 2020/852 
of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework 
to  facilitate  sustainable  investment,  and  amending  Regulation  (EU)  2019/2088  (EU  taxonomy 
Regulation) (OJ L 198, 22.6.2020, p. 13 – 43.) all include references or announced expectation for 
the submission of information on sustainability, for which data and tools will be required. 

49 

 
 
 
Table 4 gives an overview of the foreseen (re)direction or strengthening of information 
flows. More detailed descriptions are given further in the text.  

Table 4 – Overview of information flows to be (re-)directed or strengthened 

Information type 

Currently flows to 

Redirection foreseen to 

Environmental monitoring data  Commission (IPCHEM managed by 

EEA 

JRC) 

Food and feed related 
monitoring data 

Commission (IPCHEM managed by 
JRC) 

EFSA 

Human biomonitoring data 

Indoor air monitoring data 

Workplace monitoring data 

Hazard data on food contact 
materials 

Commission (IPCHEM managed by 
JRC) 

Commission (IPCHEM managed by 
JRC) 

EEA 

EEA 

Commission (IPCHEM managed by 
JRC)54 

ECHA 

Commission 

EFSA 

Regulatory process-related 
information 

ECHA 

ECHA;  requirement  to  be 
strengthened  to  add  more 
legislations  to  the  list  of 
which 
legislations 
process-related 
information 
is disseminated 

on 

(i) Monitoring data 

The information flow for environmental monitoring data starts mostly at Member State 
level. Reporting by Member States is currently typically done with specific time intervals 
to the Commission, which stores most of the information in the Information Platform for 
Chemical Monitoring (IPCHEM), while the concrete handling of the data is done by the 
EEA.  A  re-allocation  of  tasks  and  obligations  is  foreseen  under  the  proposal  for  a 
regulation on re-attribution of technical and scientific tasks to the Union agencies to reflect 
and follow today’s concrete practice.  

Considering the establishment of the common data platform on chemicals and based on 
the different agencies’ mandate and expertise, the aim is to eventually absorb IPCHEM 
into the common data platform and establish the following general information flows for 
monitoring information: 

-  Environmental  monitoring  data  flows  to  the  EEA,  from  where  it  is  made 

available to the ECHA for integration in the common data platform 

-  Food and feed related monitoring data flows to the EFSA, from where it is made 

available to the ECHA for integration in the common data platform 

54  

No established systematic data flow at EU level. Setting one under IPCHEM is an ongoing project 
between JRC and EU-OSHA.  

50 

 
 
 
 
-  Human biomonitoring data flows to the EEA, from where it is made available to 

- 

the ECHA for integration in the common data platform 
Indoor air monitoring data flows to the EEA, from where it is made available to 
the ECHA for integration in the common data platform 

Besides these regulated data flows, a solution is needed for the handling and hosting of 
orphan chemicals monitoring data contained in IPCHEM, such as data generated within 
the context of research projects or implementation plans and outside the context of any 
legal obligations. The most efficient solution identified is to empower the Commission 
to request an agency to host and maintain such data based on its mandate and expertise, 
from where it is made available to the ECHA for integration in the common data platform.  

(ii) Process-related data 

The Activities Coordination Tool (ACT) and its public version, PACT, is a voluntarily 
established information system developed and operated by the ECHA which provides an 
up-to-date  overview  of  all  planned  and  ongoing  initiatives  on  chemicals  by  authorities 
under  Regulation  (EC)  1907/2006  concerning  the  Registration,  Authorisation  and 
Restriction  of  Chemicals  (REACH)  (‘REACH’)  and  Regulation  (EC)  1272/2008  on 
classification,  labelling  and  packaging  of  substances  and  mixtures  (‘CLP’).  PACT 
increases the transparency and predictability of authorities’ work leading up to the more 
formal  processes  under  REACH  and  CLP,  as  early  information  allows  stakeholders  to 
better predict which substances may be addressed by which formal risk management route 
in the future. Similarly, the tool promotes the coordination of safety assessment activities 
across EU legislation, as authorities are informed about each other’s plans and intentions.  

A  similar  tool  is  the  OpenEFSA  portal55,  a  single  public  interface  for  all  information 
related to EFSA’s scientific work. Risk assessment processes can be followed from  the 
receipt of a dossier to the adoption of an opinion with the dissemination of the status of 
assessments,  dossier  and  studies  (non-confidential  versions),  meeting  agenda,  info  on 
experts etc.  

(P)ACT and OpenEFSA disseminate very similar information, although some differences 
exist (some of the information shared through OpenEFSA does not apply to the regulatory 
processes covered by (P)ACT). An overview of the information disseminated through both 
interfaces is given in Table 5. 

Table 5 – overview of dissemination of information through PACT and OpenEFSA 

Information  

Disseminated via PACT  Disseminated via OpenEFSA 

Submitter or responsible actor for the process or 
activity*  
Status of the process or activity  

Outcome of the process or activity  

Where applicable, date of intention, completion, 
and latest update  
Where applicable, reports or opinions adopted as an 
outcome of the process or activity  

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

55  

Open EFSA (europa.eu) 

51 

 
 
 
Supporting information for the process or activity  

Substance name, EC number, CAS number, and 
additional information on the substance 
Concern related to the substance  

Pre-submission advice  

Regulations related to the substance application  

Where applicable, the mandate number  

Where applicable, the dossier number  

Food domain  

Yes 

Yes 

Yes 

No 

No 

No 

No 

No 

Yes 

Yes** 

No 

Yes 

Yes 

Yes*** 

Yes**** 

Yes 

* For the pieces of legislation currently covered by (P)ACT, the submitter or responsible actor is typically a 
Member State or the Commission; in OpenEFSA, the submitter is typically an applicant (business operator) 
**  In  OpenEFSA, all  applications  received  by  the  EFSA  are  also  given  an  application number  which  is 
communicated to the applicant.  
*** An attached link allows to view whether the mandate is external or internal, the requestor, the subject of 
the mandate, and the initiation and decision date. Additionally, it allows viewing other submissions under 
the same mandate, their status and food domain.  
**** An attached link (if provided) allows to view the general information of the dossier (food domain, 
submitters,  the  subject  of  the  dossier),  administrative  information  of  the  dossier  (this  can  be  the  scope, 
applicant’s name, information if data-sharing agreement is in place, existing authorisation in the related EU 
legislation, additional information), public summary of the dossier, and general information on the technical 
dossier (excluding sections claimed confidential).   

In order to support and consolidate a one substance, one assessment approach, and taking 
into consideration the fact that ECHA will also set up and host the common data platform 
on chemicals, it is appropriate to formalise the (P)ACT system and progressively add 
relevant  pieces  of  chemicals  legislation.  The  information  from  the  OpenEFSA  portal 
would consequently be made available through (P)ACT. As to the concrete information to 
be disseminated, a list of minimum information would be specified, to which additional 
types of information can be specified for dissemination, based on agreements reached in 
the common data platform’s steering committee.  

Based on an assessment of pieces of chemicals legislation, Table 6 lists the acts that are 
considered  for  inclusion  in  the  (P)ACT  approach  based  on  the  acts’  coverage  of  safety 
assessment processes and initiatives (the table also provides an indication of processes in 
those pieces of legislation relevant for (P)ACT. 

Table 6 – Legislations considered for inclusion in (P)ACT 

Legislation to be included in (P)ACT 

Processes to be covered ad minimum 

Council Regulation (EEC) No 315/93 of 8 February 1993 laying 
down Community procedures for contaminants in food (OJ L 037, 
13.2.1993, p.1) 

Safety assessment 

Directive  2004/37/EC  of  the  European  Parliament  and  of  the 
Council  of  29  April  2004  on  the  protection  of  workers  from  the 
risks related to exposure to carcinogens or mutagens at work (Sixth 
individual Directive within the meaning of Article 16(1) of Council 
Directive 89/391/EEC) (OJ L 158, 30.4.2004, p.50) 

- Setting EU OELs;  

- Setting national OELs 

Council Directive 98/24/EC of 7 April 1998 on the protection of 
workers  from  the  risks  related  to  chemical  agents  at  work 

- Setting EU OELs;  

- Setting national OELs 

52 

 
 
 
 
 
(fourteenth  individual  Directive  within  the  meaning  of  Article 
16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11) 

Directive  2000/53/EC  of  the  European  Parliament  and  of  the 
Council of 18 September 2000 on end-of life vehicles (OJ L 269, 
21.10.2000, p. 34) 

Review of exemptions 

Directive  2001/83/EC  of  the  European  Parliament  and  of  the 
Council of 6 November 2001 on the Community code relating to 
medicinal products for human use (OJ L 311, 28.11.2001, p. 67) 

Environmental safety assessment of product 

Regulation (EC) No 178/2002 of the European Parliament and of 
the Council of 28 January 2002 laying down the general principles 
and  requirements  of  food  law,  establishing  the  European  Food 
Safety  Authority  and  laying down  procedures  in  matters  of  food 
safety (OJ L 031, 1.2.2002, p. 1) 

- Development of scientific opinion by EFSA 
(not already covered by GFL related legislation) 

- Scientific and technical assistance, scientific 
studies and collection of data 

Directive  2002/32/EC  of  the  European  Parliament  and  of  the 
Council of 7 May 2002 on undesirable substances in animal feed 
(OJ L 140, 30.5.2002, p. 10) 

Safety assessment 

Regulation (EC) No 1831/2003 of the European Parliament and of 
the Council of 22 September 2003 on additives for use in animal 
nutrition (OJ L 268, 18.10.2003, p. 29) 

Safety assessment 

Regulation (EC) No 726/2004 of the European Parliament and of 
the Council of 31 March 2004 laying down Union procedures for 
the authorisation and supervision of medicinal products for human 
use  and  establishing  a  European  Medicines  Agency  (OJ  L  136, 
30.4.2004, p. 1) 

Environmental safety assessment of product 

Regulation (EC) No 1935/2004 of the European Parliament and of 
the Council of 27 October 2004 on materials and articles intended 
to  come  into  contact  with  food  and  repealing  Directives 
80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4) 

Safety assessment 

Directive  2004/107/EC  of  the  European  Parliament  and  of  the 
Council  of  15  December  2004  relating  to  arsenic,  cadmium, 
mercury, nickel and polycyclic aromatic hydrocarbons in ambient 
air (OJ L 023, 26.1.2005, p. 3) 

Assessment of ambient air concentrations and 
deposition rates 

Regulation (EC) No 396/2005 of the European Parliament and of 
the  Council  of  23  February  2005  on  maximum  residue  levels  of 
pesticides  in  or  on  food  and feed  of plant  and  animal origin  and 
amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 
1) 

Safety assessment as part of the reviewing, 
amending, setting, deleting of MRLs 

Commission Regulation (EC) No 401/2006 of 23 February 2006 
laying down the methods of sampling and analysis for the official 
control  of  the  levels  of  mycotoxins  in  foodstuffs  (OJ  L  070, 
9.3.2006, p. 12) 

Safety assessment 

53 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Commission Regulation (EC) No 1882/2006 of 19 December 2006 
laying  down  methods  of  sampling  and  analysis  for  the  official 
control  of  the  levels  of  nitrates  in  certain  foodstuffs  (OJ  L  364, 
20.12.2006, p. 25) 

Safety assessment 

Directive  2006/118/EC  of  the  European  Parliament  and  of  the 
Council  of  12  December  2006  on  the  protection  of  groundwater 
against pollution and deterioration (OJ L 372, 27.12.2006, p. 19) 

- Limit value derivation EU and national 

- Addition/removal of substances to watch list 

Commission  Regulation  (EC)  No  429/2008  of  25  April  2008  on 
detailed  rules  for  the  implementation  of  Regulation  (EC)  No 
1831/2003  as  regards  the  preparation  and  the  presentation  of 
applications  and  the  assessment  and  the  authorisation  of  feed 
additives (OJ L 133, 22.5.2008, p. 1) 

Safety assessment 

Regulation (EC) 1907/2006 of the European Parliament and of the 
Council  of  18  December  2006  concerning  the  Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive 
1999/45/EC  and  repealing  Council  Regulation  (EEC)  No 793/93 
and Commission Regulation (EC) No 1488/94 as well as Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC, 
93/67/EEC, 93/105/EC, and 2000/21/EC (OJ L 396, 30.12.2006, p. 
1) 

Directive  2008/105/EC  of  the  European  Parliament  and  of  the 
Council of 16 December 2008 on environmental quality standards 
in the field of water policy, amending and subsequently repealing 
Council  Directives  82/176/EEC,  83/513/EEC,  84/156/EEC, 
84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of 
the European Parliament and of the Council (OJ L 348, 24.12.2008, 
p. 84) 

Regulation (EC) No 1272/2008 of the European Parliament and of 
the Council of 16 December 2008 on classification, labelling and 
packaging of chemicals of substances and mixtures, amending and 
repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1) 

-  Data  generation  and  assessment  (dossier  and 
substance evaluation)  
- Assessment of regulatory needs 

-  Regulatory  risk  management  –  harmonised 
classification and labelling SVHC identification, 
recommendations 
the 
Authorisation List, restrictions 

inclusion 

for 

in 

- EQS derivation EU and national 

- Addition/removal of substances to watch list 

Harmonised classification and labelling 

Regulation (EC) No 1331/2008 of the European Parliament and of 
the  Council  of  16  December  2008  establishing  a  common 
authorisation procedure for food additives, food enzymes and food 
flavourings (OJ L 354, 31.12.2008, p. 1) 

Safety assessment 

Regulation (EC) No 1332/2008 of the European Parliament and of 
the Council of 16 December 2008 on food enzymes and amending 
Council  Directive  83/417/EEC,  Council  Regulation  (EC)  No 
1493/1999,  Directive 
Council  Directive 
2001/112/EC,  and  Regulation  (EC)  No  258/97  (OJ  L  354, 
31.12.2008, p.7) 

2000/13/EC, 

Safety assessment 

54 

 
 
 
 
 
 
 
 
 
 
 
 
Regulation (EC) No 1333/2008 of the European Parliament and of 
the  Council  of  16  December  2008  on  food  additives  (OJ  L  354, 
31.12.2008, p. 16) 

Safety assessment 

Regulation (EC) No 1334/2008 of the European Parliament and of 
the Council of 16 December 2008 on flavourings and certain food 
ingredients with flavouring properties for use in and on foods and 
amending  Council  Regulation  (EEC)  No  1601/91,  Regulations 
(EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC 
(OJ L 354, 31.12.2008, p. 34) 

Safety assessment  

Directive  2009/32/EC  of  the  European  Parliament  and  of  the 
Council of 23 April 2009 on the approximation of the laws of the 
Member  States  on  extraction  solvents  used  in  the  production  of 
foodstuffs and food ingredients (OJ L 141, 6.6.2009, p. 3) 

Safety assessment  

Regulation (EC) No 470/2009 of the European Parliament and of 
the Council of 6 May 2009 laying down Community procedures for 
the  establishment  of  residue  limits  of  pharmacologically  active 
substances  in  foodstuffs  of  animal  origin,  repealing  Council 
Regulation 
(EEC)  No  2377/90  and  amending  Directive 
2001/82/EC  of  the  European  Parliament  and  of  the  Council  and 
Regulation (EC) No 726/2004 of the European Parliament and of 
the Council (OJ L 152, 16.6.2009, p. 11) 

Safety assessment as part of the reviewing, 
amending, setting or deleting of MRLs 

Directive  2009/48/EC  of  the  European  Parliament  and  of  the 
Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, 
p. 1) 

Safety assessment 

Regulation (EC) No 1107/2009 of the European Parliament and of 
the  Council  of  21  October  2009  concerning  the  placing  of  plant 
protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1) 

Safety assessment as part of the substance (re-
)approval process 

Directive  2009/148/EC  of  the  European  Parliament  and  of  the 
Council of 30 November 2009 on the protection of workers from 
the  risks  related  to  exposure  to  asbestos  at  work  (OJ  L  330, 
16.12.2009, p. 28) 

Setting new OELs 

Regulation (EC) No 1223/2009 of the European Parliament and of 
the Council of 30 November 2009 on cosmetic products (OJ L 342, 
22.12.2009, p. 59) 

Safety assessment 

Commission Regulation (EU) No 37/2010 of 22 December 2009 
on  pharmacologically  active  substances  and  their  classification 
regarding maximum residue limits in foodstuffs of animal origin 
(OJ L 015, 20.1.2010, p. 1) 

Safety  assessment  as  part  of  the  reviewing, 
amending, setting or deleting of MRLs 

Directive  2011/65/EU  of  the  European  Parliament  and  of  the 
Council  of  8  June  2011  on  the  restriction  of  the  use  of  certain 
hazardous substances in electrical and electronic equipment (OJ L 
174, 1.7.2011, p. 88) 

Review of exemptions 

55 

 
 
 
 
 
 
 
 
 
 
 
Regulation (EU) No 528/2012 of the European Parliament and of 
the Council of 22 May 2012 concerning the making available on 
the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1) 

Evaluation of active substance 

Commission Regulation (EU) 2017/644 of 28 March 2007 laying 
down methods of sampling and analysis for the control of levels of 
dioxins,  dioxin-like  PCBs  and  non-dioxin-like  PCBs  in  certain 
foodstuffs and repealing Regulation (EU) No 589/2014 (OJ L 92, 
6.4.2017, p. 9) 

Safety assessment 

Commission  Regulation  (EU)  2017/880  of  23  May  2017  laying 
down rules on the use of a maximum residue limit established for 
a pharmacologically active substance in a particular foodstuff for 
another foodstuff derived from the same species and a maximum 
residue limit established for a pharmacologically active substance 
in  one  or  more  species  for  other  species,  in  accordance  with 
Regulation (EC) No 470/2009 of the European Parliament and of 
the Council (OJ L 135, 24.5.2017, p. 1) 

Commission Implementing Regulation (EU) 2018/470 of 21 March 
2018  on  detailed  rules  on  the  maximum  residue  limit  to  be 
considered  for  control  purposes  for  foodstuffs  derived  from 
animals  which  have  been  treated  in  the  EU  under  Article  11  of 
Directive 2001/82/EC (OJ L 79, 22.3.2018, p 16) 

Safety  assessment  as  part  of  the  reviewing, 
amending, setting or deleting of MRLs 

Safety  assessment  as  part  of  the  reviewing, 
amending, setting or deleting of MRLs 

Commission  Regulation  (EU)  2018/782  of  29  May  2018 
establishing the methodological principles for the risk assessment 
and risk management recommendations referred to in Regulation 
(EC) No 470/2009 (OJ L 132, 30.5.2018, p. 5) 

Safety  assessment  as  part  of  the  reviewing, 
amending, setting or deleting of MRLs 

Regulation  (EU)  2019/4  of  the  European  Parliament  and  of  the 
Council of 11 December 2018 on the manufacture, placing on the 
market and use of medicated feed, amending Regulation (EC) No 
183/2005  of  the  European  Parliament  and  of  the  Council  and 
repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1) 

Safety assessment of product 

Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the 
Council  of  11  December  2018  on  veterinary  medicinal  products 
and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43) 

Safety assessment of product 

Regulation (EU) 2019/1021 of the European Parliament and of the 
Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 
25.6.2019, p. 45) 

-  Proposal  to  list  substance  under  Stockholm 
Convention on persistent organic pollutants 

- Listing of substances in any of the Annexes 

- Setting of unintentional trace contaminant limit 

56 

 
 
 
 
 
 
 
 
 
 
 
 
 
Directive (EU) 2020/2184 of the European Parliament and of the 
Council of 16 December 2020 on the quality of water intended for 
human consumption (OJ L 435, 23.12.2020, p. 1) 

Safety assessment of contact materials 

4.2.2. Addressing the problem that chemicals data is not always interoperable 

In  order  to  ensure  that  chemicals  data  is  interoperable,  the  only  viable  and  effective 
approach is imposing the use of standard data formats and controlled vocabularies for 
the  transfer  of  information  by  the  EU  agencies  to  the  common  data  platform  and  in 
particular imposing the use of IUCLID for the transfer of chemicals data by the EFSA for 
a limited number of specific pieces of legislation. A particular focus needs to be given to 
the  establishment  and  use  of  a  common  set  of  substance  identifiers  across  chemicals 
legislation.  This  would  not  necessarily  prohibit  and  limit  the  use  of  specific  substance 
identifiers commonly used in specific sectors (e.g. International Nomenclature of Cosmetic 
Ingredients (INCI) in the cosmetics sector); indeed, such specific identifiers could be added 
for specific data sets.  

A mandate would be created for EU agencies to establish such formats and controlled 
vocabularies, which would also be made available through the CDPC. The use of those 
formats and vocabularies would be made obligatory for the provision of information to the 
CDPC. 

(i) Progressive move to the use of IUCLID  

Several  pieces  of  EU  legislation  already  require  the  use  of  IUCLID  and  other  relevant 
OECD  harmonised  templates  (OHTs).  IUCLID  consists  of  templates  on core  data  (e.g. 
physical and chemical properties, ecotoxicological / toxicological information), OHTs and 
templates  related  to  specific  regulatory  activities  (e.g.  Regulation  (EU)  528/2012 
concerning the making available on the market and use of biocidal products, REACH and 
Regulation  (EC)  1107/2008  concerning  the  placing  of  plant  protection  products  on  the 
market).  IUCLID  and  OHTs  specifically  are  based  on  formats  which  are  the  result  of 
harmonisation reached at OECD level, as well as between regulatory programmes. 

Based  on  a  categorisation  of  chemicals  legislation  according  to  the  datasets56  they  are 
linked  to  and  the  possibility  for  coverage  by  an  OHT,  the  following  pieces  of  Union 
legislation  were  identified  as  suitable  candidates  for  a  progressive  move  to  the  use  of 
IUCLID: 

-  Regulation (EC) No 1831/2003 on additives for use in animal nutrition 
-  Regulation  (EC)  No  1935/2004  on  materials  and  articles  intended  to  come  into 

contact with food 

-  Regulation (EC) No 1331/2008 establishing a common authorisation procedure for 

food additives, food enzymes and food flavourings  

56  

Sets of information considered were the following: substance identity; hazard properties; physico-
chemical data; information on use of chemicals; volume data and speciation thereof; exposure data; 
occurrence  and  monitoring  data;  emission;  legislative  and  process  related  information;  agency 
reports/agency opinions.  

57 

 
 
 
 
-  Regulation (EC) No 1332/2008 on food enzymes 
-  Regulation (EC) No 1333/2008 on food additives  
-  Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with 

flavouring properties for use in and on foods 

-  Regulation (EC) No 1223/2009 on cosmetic products  
-  Commission  Regulation  (EU)  No  234/2011  implementing  Regulation  (EC)  No 
1331/2008 establishing a common authorisation procedure for food additives, food 
enzymes and food flavourings  

-  Directive 2009/48/EC on the safety of toys  

(ii) Other standard data formats, and controlled vocabularies 

For some data categories IUCLID is not appropriate for use and the adoption of new OHTs 
would be required. This is for example the case for exposure and use related information 
as well as monitoring data. The most effective and efficient approach is to mandate EU 
agencies to establish standard formats for data they receive under the various pieces of 
legislation  based  on  their  mandate  and  expertise.  Data  received  under  those  pieces  of 
legislation would need to be provided to the ECHA in the established standard format for 
integration in the common data platform on chemicals. In order to ensure coherence to the 
extent possible between different data formats, agencies would be required to cooperate 
when establishing formats. A similar approach is considered to be the best possible way 
forward for the establishment and use of controlled vocabularies. 

4.2.3. Addressing the problem that chemicals data is not always accessible  

Data sharing and data dissemination 

the 

To  address 
limited 
availability/accessibility of data across the chemicals regulatory framework two possible 
options were identified: 

issue  of  different 

transparency 

rules  and 

the 

Option  

Description of option  

1 

2 

Harmonise transparency rules across the chemicals regulatory framework 

Apply the originator principle 

1.  Apply harmonised transparency rules across the chemicals regulatory framework 

Under this option, the transparency rules applicable under the Transparency Regulation 
(and applicable to all chemicals subject to the General Food Law) would be extended to 
the entire chemicals regulatory framework. This would include the rules relating to 
confidentiality  claims.  This  would  mean  that  for  chemicals  outside  the  applicability 
domain  of  the  General  Food  Law,  besides  the  information  that  is  already  made  public 
today, additional information might need to be disseminated, and more importantly, that 
requirements for the verification of confidentiality claims may change.  

58 

 
 
 
 
This  option  would  address  the  objective  of  increasing  the  general  public’s  trust  in  the 
scientific  underpinning  of  EU  decision  making  in  the  chemicals  regulatory  field.  In 
addition, it would remove the obstacle for sharing data among authorities stemming from 
different transparency rules.  

2.  Apply the originator principle 

Under this option, no horizontal harmonisation of transparency rules would be established, 
but the approach would be taken that the specific legislation under which data arrives 
first determines the transparency rules; every subsequent use of that data would have 
to follow the same (original) rules.  

This principle allows authorities to have access to all available data, including confidential 
data, without the risk that when the data is being re-used and therefore brought in the scope 
of another piece of legislation, the transparency rules of that latter piece of legislation are 
applied and information may be disclosed that would not be disclosed under the original 
legislation. Such approach also gives legal certainty to the original data submitters that the 
data they claimed confidential (i.e., not for dissemination to the general public) remains 
confidential upon re-use. 

This  option  would  address  the  abovementioned  obstacles  to  data  sharing  between 
authorities, but would not change the current dissemination practice to the general public.  

Data use 

The  entities  enabled  by  means  of  this  proposal  to  use  the  information  contained  in  the 
common  data  platform  are  public  authorities  (Commission,  EU  agencies,  and  Member 
State competent authorities), and not private parties.  

Specific conditions will need to be set for the use of information by public authorities. 
Indeed,  if  information  owned  by  a  private  party  is  used  by  a  public  authority  for  the 
fulfilment of legal duties of another private party, and without a financial compensation 
mechanism  in  place,  this  would  constitute  free  riding  of  the  latter  duty  holder  on  the 
information paid for by the former. In order to prevent this, a clear condition will need to 
be set that public authorities cannot use privately owned information for the fulfillment 
of legal obligations, including filling in data gaps in the regulatory dossiers of other duty 
holders.  Similar  conditions  already  exist  under  specific  EU  acts,  e.g.  Article  20(1)  of 
Regulation (EC) No 1831/2003 on additives for use in animal nutrition57 and Article 31 of 
Regulation (EC) No 1829/2003 on genetically modified food and feed58.  

4.2.4. Addressing the problem that there is  no default generation or submission of 
certain types of chemicals data 

57  

58  

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutrition. (OJ L 268, 18.10.2003, p. 29)  

Regulation (EC) no 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1)  

59 

 
 
 
A data generation mechanism (DGM) should allow the Commission and EU agencies, and 
possibly  national  authorities,  to  obtain  adequate  data  and  information  required  for  the 
assessment of safety and impacts of known and emerging chemicals in an efficient  and 
coherent  way,  while  maintaining  the  principle  that  the  burden  of  proof  of  the  safety  of 
chemicals is on industry. A data generation mechanism could cater for the situation where 
it is not legally possible to request data from industry or where there is an explicit reason 
why data should be generated by a non-industrial stakeholder.  

For the options identified below,  

–  ‘data  generation’  will  be  understood  as  the  intentional  production  of  new  data 
through  testing,  monitoring,  or  modelling;  in  specific  cases  the  data  generation 
may be complemented with the collection of existing data, e.g., through a literature 
search.  

–  the  term  ‘data’  means  any  data  used  for  chemical  risk  assessments,  such  as 
chemical identity, physicochemical properties, hazard data or occurrence data. It 
is not only to be understood as measurements or test data, but also includes results 
of  computer  modelling.  It  does  not  include  information  on  processes  about  the 
assessments, e.g., application for REACH authorisation, initiation of harmonised 
classification, etc. 

When establishing a DGM, the following scope and conditions are considered essential: 

•  The DGM should enable the Commission and EU agencies and possibly also 

national authorities to carry out or commission testing or monitoring.  

•  The DGM can be used to: 

o 

inform regulatory processes in which data are missing; 

o  verify the effectiveness of legal measures; 

o  generate additional data to provide additional evidence in exceptional 

cases of serious controversy on a specific substance or dossier. 

•  The DGM is complementary to any existing obligatory data generation – this 
means that the burden of proof remains on the original duty holder and the DGM 
cannot  be  used  to  fulfil  any  legal  obligation  towards  data  generation  or 
provision. 

•  The DGM should consider other existing similar tools or mechanisms to ensure 

that synergies are exploited and that resources are used efficiently. 

•  The data generated for a specific purpose (use case) should be available for re-

use in the larger context of chemicals policy and legislation. 

•  The  DGM  cannot  be  used  for  predominant  research  purposes  or  for  the 

validation of methods. 

Examples of use cases for a DGM are listed below. A prerequisite for a DGM is that the 
data generation is technically feasible, and that suitable methods and analytical protocols 
are available. 

60 

 
 
•  Absence of unequivocal data on hazards for human health or the environment in a dossier 

for harmonised classification and labelling (CLH)  

•  Absence of data or insufficient data on toxicokinetics, metabolism and distribution for 

risk assessment of a group of structurally similar substances; this data need is encountered 
by ECHA under the assessment of regulatory needs (ARN) procedure  

•  Data gap filling on mechanistic information on toxicity (from in vitro assays) to support 

grouping of structurally similar chemicals  

•  High throughput screening for specified endpoints, e.g., endocrine disruption  
•  Need for human toxicity reference values as basis for substance prioritisation e.g. under 
Directive (EU) 2020/2184 on the quality of water intended for human consumption  
•  Lack of data on chronic ecotoxicity for prioritisation of substances for inclusion in the 
watch list for surface water under Directive 2000/60/EC establishing a framework for 
Community action in the field of water policy 

•  Avoiding regrettable substitution by substances yet at lower tonnage levels or not (yet) 
marketed but within a chemical group with known members of hazard of concern e.g., 
already on the REACH Candidate List for Authorisation  

•  Lack of information on intrinsic properties including hazard data for substances not 

registered under REACH such as chemicals whose production has ceased, or that are 
produced unintentionally  

•  Need for an early warning and action system for chemicals, to ensure that EU policies 
address emerging chemical risks as soon as identified by monitoring and research.  
•  Lack of soil monitoring data for specified substances of concern, and identification of 

potential time trends. Currently, soil monitoring is done in the Land Use/Cover area frame 
statistical Survey (LUCAS)59. This is highly unstable as it depends on the financial 
resources currently put in place by the respective Commission services. Soil monitoring is 
also done in initiatives at Member State level.  

•  Need for monitoring data (water, soil, biota) in pristine, remote areas for the assessment 
of the long-range transport potential of persistent organic pollutants candidates under the 
Stockholm Convention, as well as for classification as PMT (Persistent, Mobile and 
Toxic)  

•  Need for surface water monitoring data beyond the substances on the watch lists of 

Directive 2000/60/EC, for specified substances of potential concern, to examine whether 
inclusion in the watch list would be recommendable  

•  Need for air monitoring data for specified substances of potential concern, to examine 

whether inclusion in the legislation on air quality would be recommendable  
•  Lack of deposition data on environmental contaminants (e.g., polycyclic aromatic 

hydrocarbons (PAH’s), phthalates, and other chemicals for which dietary intake is the 
major exposure route).  

•  Human biomonitoring (HBM) data for prioritised substances/groups of concern can be 

used to generate time trends for following up the effectiveness of regulatory actions and 
policies.  

•  Lack of indoor air quality monitoring data; there are some activities already at Member 

State level, but an EU-wide mechanism could ensure coordination and higher relevance to 
the EU policies.  

59  

Database - Land cover/use statistics - Eurostat (europa.eu) 

61 

 
 
 
•  Support to activities such as EUON60 that periodically compile targeted information on 
properties, uses and presence on the market for selected classes of materials (e.g. 
nanomaterials) for increased transparency 

For the establishment of a data generation mechanism, two options were identified.  

1.  Data  generation  mechanism  with  explicit  governance  structure  and  centralised 

submission and assessment procedures 

Under  this  option,  a  centralised  system  for  the  submission  of  testing  ideas  and  for  the 
assessment/prioritisation  of  submissions  would  be  established  as  well  as  a  clear 
governance structure. Member States would have the  right to  submit study requests, as 
well  as  the  Commission  and  EU  agencies.  The  entire  chemicals  regulatory  framework 
would be covered.  

The following aspects and procedural steps are addressed under this option: 

•  Submission  of  requests.  A  study  request  needs  to  comprise  a  rationale,  a 
proposal for testing, a preliminary cost estimate and the estimated timeline. 

•  Eligibility  check  of  all  requests.  Incoming  requests  are  checked  for 

completeness and for the fulfilment of any set formal requirements. 

•  Assessment  of  all  requests  (prioritisation,  resource  availability).  All 
requests for data generation need to be assessed for prioritisation and resource 
availability, so that a recommendation is available whether the data generation 
should be executed or not. 

•  Decision on what requests are approved. To move from the assessment to the 
execution  of  a  data  generation  request  different  options  exist.  In  particular, 
considerations on whether the data generation is done on the basis of a (multi)- 
annual work programme or on a rolling basis result in different sub-options. 

The following procedural steps can be distinguished in which responsibilities would need 
to be assigned at the execution stage of data generation: 

•  Sample acquisition. Depending on the type of data to be generated, the sample 

acquisition might need support from industry or Member States. 

•  Commission study. In this step the envisaged study is commissioned. 

•  Management  and  follow-up  of  study.  As  soon  as  the  study  is  carried  out 
somebody  needs  to  be  responsible  for  the  management  and  follow  up  of  the 

60  

Home - European Observatory for Nanomaterials (europa.eu) 

62 

 
 
 
 
study. This covers contacts with potential laboratories, checking of results and 
related activities. 

•  Dissemination  of  study  results.  Once  the  data  are  generated  it  needs  to  be 
ensured that the data are made publicly available. This is to be done through the 
common data platform. 

Submission  of  requests:  Besides  the  European  Commission,  EU  agencies  should  be 
allowed to submit requests. Furthermore, under this option, Member States (MS) would 
also be allowed to submit requests, because they are frequently involved in risk assessment 
processes for chemicals.  

A request should comprise a rationale, a proposal for testing, a preliminary cost estimate 
as well as the estimated timeline. The rationale should summarise the current knowledge 
and latest  relevant  findings  to  justify the request. A testing  proposal needs to  show the 
technical feasibility and should also indicate the involvement of national or EU reference 
laboratories if necessary as well as possibilities for appropriate sample acquisition. 

Governing  body:  the  Commission  would  have  the  administrative  and  financial 
responsibility for the process and mandate EU agencies according to their expertise and 
mandate  for  the  assessment  of  study  requests  as  well  as  for  the  execution  of  the  data 
generation. In case a high number of requests is submitted a prioritisation will be necessary, 
so prioritisation criteria will need to be identified. The process could be along the following 
lines: 

–  The Commission receives all study requests and distributes them to the agency 
with  the  specific  expertise  for  the  request  (mainly  EMA,  ECHA,  EFSA  and 
EEA but potentially also others like EU-OSHA). The EU agencies assess the 
conformity of the request and report back to the Commission on the outcome. 

–  For the final decision on approval of requests, an expert working group could 
be  involved,  where  the  Commission,  EU  agencies  and  Member  States  are 
represented. 

For the prioritisation, a scoring system could be set up that takes into account hazardous 
properties,  exposure  (including  environmental,  consumer  and  occupational  exposure 
pathways),  regulatory  demand,  societal  concern,  and  overall  feasibility  (technical, 
financial).  

Upon approval  of a specific study request,  the agency mandated by the Commission  is 
responsible for the commissioning and follow-up of the study: 

–  ensure  the  acquisition  of  samples  in  close  collaboration  with  industry  or 

Member States where relevant;  

–  commission the testing via appropriate laboratories;  

–  receive the results from the laboratory;  

–  feed generated data into the common data platform on chemicals;  

–  inform the Commission and the data requestor on the availability of the data;  

63 

 
 
–  propose any follow up actions concerning the data to the expert working group 

where relevant. 

Sample acquisition: in order to be able to carry out data generation appropriate samples 
are needed. Considerations on the possibilities for sample acquisition and any necessity to 
involve national and /or EU reference laboratories should be part of the data generation 
request.  

For tests related to industrial chemicals, the involvement of industry could be beneficial. 
This  is  particularly  important  in  order  to  agree  on  appropriate  samples  as  regards 
composition so that data generated is useful and suitable for risk assessments. In case of 
monitoring programs Member States could support sample acquisition. 

Admission  structure:  A  (multi-)  annual  work  program  allows  planning  safety  for  all 
actors involved and a better prioritisation of requests in general, so that the budget can be 
spent  on  the  most  important  activities.  However,  a  minor  part  of  the  budget  could  be 
reserved  for  urgent  /  interdependent  requests  as  an  ad  hoc  response  mechanism.  The 
admission structure in the form of a (multi-) annual work programme implies a defined 
timeline with set deadlines for the submission and assessment of study requests. 

Budget and resources: most likely the budget would have to come from the community 
budget. Indeed, there will be data generation procedures in which the data needs cannot 
be  allocated  to  one  or  several  specific  chemicals  (e.g.,  substances  registered  under 
REACH) and thus cannot be directly linked to specific industry organisations, from which 
a  fee  could  be  requested.  Such  cases  comprise  data  generation  in  which substances  are 
grouped or substances are monitored which are not REACH registered in the EU; also non-
target screening methods cannot be linked directly to a specific company or duty holder. 

2.  Obligation on ECHA to commission scientific studies for the performance of its mission 
In this option, an obligation would be conferred on ECHA  similar to the one on EFSA 
under Article 32 of Regulation (EC) 178/2002: 

Article 32 

Scientific studies 

1.  Using  the  best  independent  scientific  resources  available,  the  Authority  shall 
commission scientific studies necessary for the performance of its mission. Such studies 
shall  be commissioned in  an open and transparent  fashion. The Authority shall  seek to 
avoid duplication with Member State or Community research programmes and shall foster 
cooperation through appropriate coordination.  

2. The Authority shall inform the European Parliament, the Commission and the Member 
States of the results of its scientific studies. 

EFSA would continue the operation of their mechanism to commission scientific studies, 
which is focused on the food sector. ECHA would be mandated to commission scientific 
studies for the performance of its mission, i.e. to support the implementation and evaluation 
of chemicals legislation within the mandate of ECHA. In addition, the Commission would 
be empowered to request ECHA to commission such studies as well. 

64 

 
 
This option would also foresee a requirement for ECHA and EFSA to closely cooperate 
when  commissioning  scientific  studies  to  avoid  duplication,  maximise  synergies  and 
ensure coherence of safety assessments across legislation in line with the one substance, 
one assessment objectives.  

4.2.5. Addressing the problem of an insufficient uptake of academic data 

Three options were identified for an improved uptake of academic data. The options are 
not necessarily all mutually exclusive.  

Option 

Description of option 

1 

2 

3 

Legal obligation on EU agencies 

Legal obligation on industry duty holders 

Rely on OECD guidance 

1.  Legal obligation on EU agencies 

A  legal  requirement  would  be  put  on  EU  agencies  to  perform  a  literature  search  on  a 
regular basis. Searches could be limited to specific (categories of) chemicals. Results of 
the search are made available to duty holders in a structured way through a repository so 
they can be taken into account in their safety assessment duties. 

Under one sub-option, the repository would contain the links to scientific papers with 
relevant information on a substance. This sub-option would make it clear to duty holders 
which academic studies to explore as a minimum for their legal obligations. This could 
help implement the obligation to consider all available information by defining a minimum 
set of information to consider.  

Under a second sub-option, an agency would extract the information from the relevant 
scientific  papers  and  make  it  available  in  a  repository  (made  available  through  the 
common  data  platform  on  chemicals),  comparable  to  the  Endocrine  Active  Substance 
Information  System  EASIS61.  This  would  allow  duty  holders  not  only  to  know  which 
academic studies to consider but would make the use of data very easy for them.  

2.  Legal obligation on industry duty holders 

Under one sub-option, a new legal obligation would be created for the entire chemicals’ 
regulatory framework to collect and consider academic data and to document the search 
and its outcomes. 

In some legislations the requirement to consider academic data is already clearly specified 
e.g., for the assessment of endocrine disrupting properties of biocidal products and plant 

61  

Endocrine Active Substances Information System (EASIS).  

65 

 
 
 
 
protection  products  under  Regulation  528/201262  and  Regulation  1107/200963 
respectively.  For the authorisation  of food improvement agents64, the documentation on 
the  data  gathering  procedure  also  needs  to  be  submitted,  including  the  literature  search 
strategy  (i.e.,  the  assumptions  made,  key  words  used,  databases  used,  the  time  period 
covered, limitation criteria etc.) and the comprehensive outcome of the search. 

A consistent legal obligation would also apply to legislation where the decision-maker is 
required to gather the relevant information for setting or reviewing limits in the field of 
e.g., occupational exposure, protection of air and water and consumer protection, e.g., by 
limits for certain substances in cosmetics but also for processes like REACH restrictions 
or the nomination of persistent organic pollutants. 

Care  should  be  taken  to  avoid  putting  an  inappropriate  focus  on  academic  database 
searches: in some processes, other approaches to collect relevant information are used in 
addition to or even instead of the classical literature search, e.g. calls for evidence or other 
consultation activities. In some processes, monitoring data and grey literature might be the 
actual  relevant  sources.  Furthermore,  some  processes,  e.g.,  REACH  restrictions  or  the 
setting  of  an  environmental  quality  standard  (EQS),  are  well  established  processes  and 
include  an  additional  consultation  step  by  an  independent  committee.  Against  this 
background, it can be argued that the quality of the uptake of the relevant information is 
already ensured, and an additional obligation is not needed. 

Under a second sub-option, existing legal obligations would be strengthened. 

Regulation  (EU)  No  234/2011  establishing  a  common  authorisation  procedure  for  food 
additives, food enzymes and food flavourings65 requires the following documentation as 
part of the general provisions on data required for risk assessment according to Article 5: 

The documentation of the procedure followed when gathering the data shall be provided, 
including the literature search strategies (assumptions made, key words used, databases 
used, time period covered, limitation criteria, etc.) and a comprehensive outcome of such 
search. 

The  documentation  requirement  ensures  that  the  collection  and  consideration  of 
academic data actually takes place and can be retraced and verified. 

A requirement like the one above could be put in place for other legislations. Focus could 
be  put  in  the  first  place  on  instances  where  industry  has  an  information  collection  and 
submission obligation, e.g., for registration under REACH, notification under CLP or for 

62  

63  

64  

65  

Regulation  (EU)  528/2012  concerning  the  making  available  on  the  market  and  use  of  biocidal 
products. OJ L 167 27.6.2012, p. 1. 
Regulation (EC) 1107/2009 concerning the placing of plant protection products on the market and 
repealing Council Directives 79/117/ EEC and 91/414 EEC. OJ L 309 24.11.2009, p. 1. 
Commission Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008 of the 
European Parliament and of the Council establishing a common authorisation procedure for food 
additives, food enzymes and food flavourings. OJ L 064 11.3.2011, p. 15. 
EUR-Lex - 32011R0234 - EN - EUR-Lex (europa.eu) 

66 

 
 
 
cosmetic products, or approval and authorisation processes for plant protection products 
and biocidal products. 

A choice is  also  to  be made between a requirement  to  only provide a  summary of the 
search strategy and a requirement to provide a summary of the search strategy as well as 
an overview of the outcome of the search. 

3.  Rely on OECD guidance 

The  Commission  initiated  an  OECD  project  under  the  Working  Party  for  Hazard 
Assessment (WPHA) on developing (i) a guidance setting minimum quality and reporting 
requirements  to  help  researchers  to  design,  perform  and  report  studies  in  a  way  that  is 
acceptable for the regulatory assessment and (ii) a search guide for finding and retrieving 
relevant academic data. The project is foreseen to end by the end of 2024. 

A follow-up to the development of the guidance document would be the adoption of an 
OECD recommendation to research funders of the member countries and publishers to 
require the use of the guidance setting minimum quality and reporting requirements for 
data generation and reporting.   

Under this option, no action is needed in the context of the legislative proposal at hand. 
While the adoption of both documents and the potential OECD recommendation will not 
create any legal obligation, they will independently contribute to an improvement in the 
uptake  of  academic  data.  This  would  therefore  be  complementary  to  any  legal 
obligations that may be introduced. 

4.2.6. Addressing the problem that duty holders may not report all study results  

To ensure that the EU risk assessor has knowledge of all studies performed by an applicant, 
the  Transparency  Regulation  contains  a  requirement  to  notify  studies  that  are 
commissioned  or  intended  to  be  carried  out  in  the  context  of  the  preparation  of  an 
application for approval process in the food chain, at pre-submission phase. Besides the 
applicant  (business  operator),  where  a  study  is  commissioned  with  a  laboratory,  the 
contracted laboratory is also required to notify. Information about the notified studies is 
made public once a corresponding valid application has been submitted and information 
on  it  is  made  public  in  accordance  with  the  applicable  rules  on  transparency.  The 
Transparency  Regulation  also  provides  for  procedural  consequences  in  case  of  non-
compliance. 

Under the current initiative it was evaluated whether there is a need for and added value of 
such a notification mechanism beyond the food sector (the outcome of this evaluation is 
reflected  in  the  summary  of  the  stakeholder  consultation  in  Annex  2).  In  addition,  we 
developed different options for the establishment of such notification requirement. 

Five  aspects  were  considered  for  the  design  of  the  options  for  extending  the  study 
notification requirement. Different combinations of different possibilities for each of the 
five aspects led to the identification of three main options. 

67 

 
 
•  Scope. The scope of the extension of the study notification obligation to the rest 
of  the  chemicals  sector  should  be  scaled  to  ensure  maximal  effectiveness  and 
maintain a positive benefit/cost ratio. The most effective option would be to require 
all  studies  commissioned  or  conducted  to  support  a  regulatory  process  to  be 
notified  when  commissioned  or  carried  out.  In  order  to  understand  what  is 
considered to be a ‘study’, the Transparency Regulation and its related guidance 
documents were used as a reference. A study thus means an experiment or set of 
experiments  in  which  a  chemical  substance  or  mixture,  or  a  group  of  chemical 
substances  or  mixtures,  is  examined  under  laboratory  conditions  or  in  the 
environment  to  obtain  data  with  respect  to  the  properties  or  the  safety  of  that 
substance or mixture, or group of substances or mixtures. This full coverage would 
affect the whole chemicals sector and generate the most study notifications but 
would  also  result  in  a  more  significant  total  compliance  cost  for  the  industry 
(operators and laboratories) compared to a narrower scope. Other possibilities for 
this aspect include requiring notification only for  specific groups or sectors of 
chemicals  (e.g.  only  substances  subject  to  REACH  registration  requirement) 
and/or for specific studies.  

•  Database setup. The existing EFSA database (holding study notifications done 
under the Transparency Regulation) could be the starting point for the extended 
requirement.  It  could  receive  and  store  new  notifications,  which  would  be 
accessible by the relevant assessors to cross-check the notifications and the studies 
in  a  regulatory  dossier.  The  advantage  of  this  choice  would  be  to  leverage  the 
already existing register infrastructure. 

Alternatively,  a  central  repository,  part  of  the  common  data  platform  on 
chemicals, accessible to  all relevant  assessors  and linked to regulatory dossiers, 
could  be  set  up.  Monitoring  and  enforcement  of  study  notifications  would  be 
carried out by the entity in charge of the assessment or regulatory process. 

A  third  possibility  could  be  to  operate  the  two  databases  separately  and 
independently from each other: EFSA continues to operate its existing database and 
ECHA  would  set  up  a  database  for  the  remainder  of  the  study  notifications. 
Notifications made to EFSA would in any event also be made available through the 
common data platform on chemicals once a decision is taken by the EFSA on the 
disclosure  of  the  studies  accompanying  an  application  in  accordance  with  the 
confidentiality rules under the Transparency Regulation. 

•  Sanctions. In the case of missing study notifications or missing studies in a dossier, 
the  same  sanctions  as  under  Article  32b  (4)  Transparency  Regulation  could  be 
considered: applications are considered invalid or inadmissible when supported by 
studies not previously notified, or vice versa, when notified studies are not taken 
up  in  the  dossier,  without  valid  justification.  Applicants  may  resubmit  the 
application after notifying the missing study or including the missing study results 
and after a 6-month waiting period (after notification or inclusion of the study).  

This  type  of  sanction,  which  essentially  entails  a  delay  in  market  access,  can 
however  not  be  applied  to  all  pieces  of  legislation.  For  example,  the  REACH 
registration  process  is  not  a  market  approval  or  authorisation  process  like  the 

68 

 
 
processes  covered  by  the  Transparency  Regulation.  Once  companies  have 
registered their substances, they can place their substance on the market and do not 
need  to  wait  for  any  approval  or  authorisation  by  an  EU  body.  In  those  cases, 
standard enforcement activities by Member States are considered to apply.  

•  Transparency.  With  regard  to  making  the  notification  information  publicly 
available, a balance needs to be struck between transparency on the one hand and 
protection of innovation  and competitiveness on the other. One possible way to 
deal with this is to carefully choose the timing of the publication of information. 
Once  a  regulatory  dossier  relating  to  a  notified  study  is  submitted,  it  appears 
appropriate to also publish the notification information. This approach is similar 
to the one under the Transparency Regulation.   

The assessor would in any case have access to the information from the moment 
of notification. This serves to inform the assessor on what is to come in terms of 
assessment work as well as on the progress in a procedure. 

•  Content. The base option is the specification in Article 32 of the Transparency 
Regulation: title and scope of any study carried out by the applicant to support an 
application or a notification, as well as the laboratory or testing facility if the study 
is commissioned, and its starting and planned completion dates (for laboratories: 
the scope, planned start and end date, and commissioning operator). 

Based on different combinations of the dimensions described above, three  options were 
identified. These options are presented below, ranked according to the magnitude of the 
induced changes compared to the status quo (no notification requirement), with option A 
bringing about least changes and option C most. A combination of elements is possible, 
thus creating more options. 

Option A 

Option B 

Option C 

Scope 

Subset of the chemicals: 
substances subject to 
REACH registration 

Laboratories co-notify 

Database set-up  Dual notification databases 

Food sector notifications to 
EFSA database 

Rest of notifications to new 
ECHA database 

All notifications accessible 
through common data 
platform 

Whole chemicals sector 

Whole chemicals sector 

Laboratories co-notify 

Laboratories co-notify 

All notifications go to existing 
EFSA notification database 

All notifications accessible 
through common data 
platform 

One notification database under 
common data platform (i.e. 
food sector notification moves 
from EFSA to ECHA) 

All notifications accessible 
through common data platform 

69 

 
 
 
 
Transparency  Made public when notified 

Pre-defined redaction rules 
and publication when ensuing 
application/registration is 
considered admissible (same 
as Transparency Regulation). 

Pre-defined redaction rules and 
publication when ensuing 
application/registration is 
considered admissible (same as 
Transparency Regulation). 

Sanctions 

Standard enforcement 
activities by Member 
States 

Market access delay where 
relevant (same as under 
Transparency Regulation)  

Market access delay where 
relevant (same as under 
Transparency Regulation)  

+ 

+ 

standard enforcement 
activities by Member States  

standard enforcement activities 
by Member States  

Content 

Substance  identity,  notifier 
identity,  study  title,  study 
scope,  and  timing  of  study 
(same 
under 
as 
Transparency Regulation). 

Substance identity, notifier 
identity, study title, study 
scope, and timing of study 
(same as under Transparency 
Regulation). 

Substance identity, notifier 
identity, study title, study scope 
and timing of study (same as 
under Transparency 
Regulation) 

+ information specific to the 
type of substance or regulatory 
process where relevant  

1.  Policy option A 

Under this option the requirement to notify studies would be extended to substances subject 
to REACH registration. A notification database would be set up and managed by ECHA 
in parallel with the existing database at EFSA. All notifications would be made available 
through the common data platform  on chemicals. Non-compliance would  be dealt with 
under normal enforcement by Member States. The notification requirement applies to both 
the applicant and the contracted laboratory where applicable (co-notification). The content 
of the notification would be the same as under the Transparency Regulation, i.e., substance 
identity,  notifier  identity,  study  title,  study  scope  and  timing  of  study.  The  information 
would be made public at the moment of notification. 

2.  Policy option B 

This option has a broader scope than option A: it includes all regulatory processes in the 
chemicals  sector.  The  existing  EFSA  notification  database  would  serve  as  a  single 
notification  point.  All  notifications  would  be  made  available  through  the  common  data 
platform. Individual agencies/competent authorities would be responsible for monitoring 
study  notifications.  In  case  of  non-compliance  (missing  study  notification),  besides 
standard enforcement by Member States, a market access delay would be applied where 
relevant.  The content  of the notification is  the same as in  option A but would  be made 
public  according  to  pre-defined  redaction  rules,  and  only  when  an  ensuing  regulatory 
dossier is considered admissible (like under the Transparency Regulation). 

3.  Policy option C 

70 

 
 
 
 
In comparison with option B, this option expands the content of the notification with more 
information  specific  to  the  type  of  chemicals  examined  in  the  study.  All  notifications, 
including  those  made  under  the  Transparency  Regulation,  would  go  to  the  ECHA  and 
would be made available through the common data platform. 

4.2.7.  Addressing  the problem  that  there  is  no  mechanism  for  the  identification  of 
emerging chemical risks 

To  ensure  coordination  in  the  generation,  compilation  and  evaluation  of  early  warning 
signals of emerging chemical risks to enable policy or regulatory follow up actions, the 
only viable and effective option identified was the establishment of an EU early warning 
and action system, serving as an EU umbrella system based on inputs from EU agencies, 
national early warning systems, national and EU initiatives, and the scientific community. 

A  proactive  and  systematic  approach  to  the  identification  of  emerging  risks  would  be 
established, with  the European Environmental Agency acting as the leader. The system 
would  consist  of  the  collection  of  early  warning  signals,  the  identification  of  potential 
emerging risks from chemicals, and a report on the findings of those activities, all to be 
presented  to  the  Commission,  relevant  EU  agencies  and  Member  State  competent 
authorities  for  identification  and  discussion  of  potential  regulatory  or  policy  follow-up. 
The system  would be developed progressively.  Initially, it would rely  on existing  early 
warning  systems  and  signals,  such  as  the  EFSA’s  emerging  risks  exchange  network 
(EREN), national warning systems (e.g. SamTox, SIGNAAL), as well as relevant existing 
data and information made available by EFSA, ECHA, EEA, EMA, EU-OSHA and the 
Commission. Progressively, more signals would be developed by the cooperating agencies 
(i.e.  EEA,  ECHA,  EFSA,  EMA,  EU-OSHA)  and  the  tools  for  early  warning  signals 
developed by the Partnership for the Assessment of Risks from Chemicals (PARC) would 
be explored and utilised as appropriate. 

The  European  Environmental  Agency  would  make  all  information  on  early  warning 
signals  for  emerging  chemical  risks  it  holds  or  hosts,  as  well  as  the  summary  report 
available to the ECHA for integration in the common data platform on chemicals.  

The  types  of  signals  that  could  feed  into  the  EU  early  warning  and  action  system  for 
emerging chemical risks include:  

• 

• 
• 

• 

• 

substances on the market currently produced and used in small quantities but with 
high growth potential, 
new substances at research and development stage not yet on the market, 
new scientific knowledge leading  to  a more critical  assessment of the risk (e.g., 
discovery of subtle effects or sensitive species), 
new substances on the market, such as recently developed substitutes for regulated 
substances, 
substances for which emerging evidence raises concerns due to:  

improvements in the sensitivity of analytical methods,  

▪ 
▪  chemical mixtures/combination effects of chemicals, 
▪  new toxicological evidence, 
▪  newly identified exposure routes, 

71 

 
 
▪ 

increasing  levels  and  scale  of  exposure  or  trends  in  the  profile  of  the 
exposure, 

▪  development of the legislation, 
▪  new susceptible at-risk population or at-risk groups.  

• 
• 

industry data (e.g., development of alternatives, production volumes) 
biological signals (e.g., biodiversity loss) 

5.  WHAT ARE THE IMPACTS OF THE IDENTIFIED OPTIONS? 

5.1. Addressing the problem that information is difficult to find, share or re-use 

and some information flows are suboptimal 

Establishment of common data platform on chemicals 

The  platform  will  exploit  opportunities  with  existing  data  through  the  creation  of  new 
services  and  a  significant  extension  of  the  possibility  to  use  data  through  an  enhanced 
interoperability of individual datasets as well as their integrated access. The latter is further 
augmented through the sustained embedded availability of targeted dedicated services such 
as a repository of reference values and information on regulatory processes.  

The sustainable benefit of the platform will come from these functionalities, applied over 
the  content  that  will  be  included  in  the  platform.  The  platform  will  operationalise  the 
ambition of the one-substance one-assessment approach, supporting quality and mutual 
coherence of assessments performed. Bringing together chemicals data in one place will 
increase findability and simplify access, which is beneficial for all users (citizens, industry 
in particular SME and microenterprises with less access to professional services, Member 
State competent authorities and EU agencies). The use of standard formats and controlled 
vocabularies will enhance interoperability of information, thus increasing its findability. 
In addition, information across regulatory dossiers will be easier to compare. An increased 
findability and comparability will in turn reduce administrative burden for risk assessors, 
which include national administrations, and have a positive impact on the effectiveness, 
efficiency and coherence of chemical safety assessments.    

Through  the  extended  utility  of  shared  information,  it  will  help  minimise  potential 
duplication of efforts and optimise data generation strategies. With an increased volume 
and transparency of data on chemical properties and supported by adequate context data 
that enables the responsible use of that chemicals data, compliance with and enforcement 
of existing obligations should be facilitated.  

Building on integrated access and services it is expected to provide additional insight into 
effective risk management measures and to facilitate the search for safe and sustainable 
alternatives,  leading  to  improvements  in  the  protection  of  human  health  and  the 
environment in accordance with the objectives of the chemicals strategy for sustainability.  

Bringing together chemicals data and being allowed to use it will increase the knowledge 
base for scientific assessments and opinions, thus improving their robustness. This will in 
turn increase the acceptance by society of conclusions and regulatory decisions. Knowing 

72 

 
 
 
through the notification of studies that all studies have been considered in an assessment 
further strengthens the trust of citizens in regulatory decisions.    

The dedicated service related to information on regulatory processes planned or ongoing 
by  the  Commission,  EU  agencies  and  Member  States  will  improve  the  coordination  of 
activities, which in turn will allow better planning for the authorities and agencies involved 
thus  increasing  efficiency.  The  information  will  also  allow  better  predictability  and 
planning for industry, facilitating receipt of comprehensive but also consistent input to the 
activities, where required. It will be easier for industry but also other stakeholders to know 
when and how to contribute to regulatory processes.  

The dedicated service related to obligations under EU legal acts on chemicals will be very 
valuable for industry, and in particular for SMEs  and  microenterprises, to  easily get  an 
overview of their legal obligations, which will give them certainty on what exactly their 
duties  are.  Acting  with  such  full  knowledge  in  turn  supports  compliance  and 
correspondingly reduces burden on national authorities.  

While the database of environmental sustainability information is only being designed, and 
information is only started to be generated in more systemic manner and the regulatory 
tools  mandating  use  of  such  data  are  still  very  limited,  it  is  clear  from  the  trends  that 
ensuring in advance a common focus can dramatically increase efficiency in collection, 
validation, verification and consistency of sustainability information on chemicals, and its 
use both in regulatory and non-regulatory domain.  

The establishment and operation of the platform will not impose any costs on industry. 
Business operators will have to continue to fulfil their legal obligations as they are doing 
today under relevant specific pieces of legislation. The platform is not associated with any 
new information requirements or other obligations for industry. 

The establishment of the platform will however be associated with significant costs for the 
EU agencies, but they should principally be seen as investment in technical progress within 
the  data  economy,  enhancing  the  value  of  existing  and  future  data.  The  task  requires 
investment  in  entirely  new  data  structures  and  IT  systems/capabilities,  principally  on 
ECHA’s side, but also on the side of other EU agencies as data source owners who are to 
prepare datasets for integration in the platform. 

The platform’s development is centred around three main elements: 

•  design and construction of a data container, i.e. the technical platform solution 
and the data definitions and ingestion mechanisms that enable it to receive data. 
While  ECHA  will  be  responsible  for  the  IT  infrastructure  of  the  data  container, 
other agencies will need to be involved in cooperation (and – depending on the data 
type – lead) on setting data definitions and supporting the general governance of 
the platform covering the determination of basic functionalities (ingestion, use and 
outputs, dedicated products featuring in the platform) and further evolution inter 
alia.  

•  data  content  activities:  data  transformation,  curation  and  confidentiality 
assessment  as  well  as  the  upload  of  integrated  datasets  will  remain  the 
responsibility  of  the  data  source  owners  (i.e.  agencies),  unless  explicitly  agreed 

73 

 
 
otherwise,  based  on  commonly  agreed  rules  and  vocabularies  and  supported  as 
appropriate  with  ingestion tools. For data source  owners, this  work will overlap 
with  the  work  on  formats  and  controlled  vocabularies  of  their  datasets  and  the 
organisation  of  related  dataflows  from  original  data  providers  (e.g.  industry 
registrants, applicants, Member States). 

•  preparation of dedicated services available in the platform will include work on 
technical platform functionality as well as on data content. Examples of dedicated 
services are a repository of reference values, information on legal obligations, and 
a database on study notifications (see also section 4.2.1).  

The  container/content  approach  to  the  development  of  the  technical  platform  will  be 
automated  to  the  extent  possible,  using  existing  ‘building  blocks’  i.e.  relevant  services 
provided by the public cloud environment where the platform is expected to be hosted. It 
will  follow  the  “intentional  architecture,  emergent  designs”  principle,  leading  to  the 
container with  availability of all necessary networking and development  services in  the 
public cloud, with the necessary management tools, identity rules, enforceable policies and 
security  controls,  and  a  modular  and  extensible  character  for  further  evolution  of  e.g. 
analytical functionalities.  

Each dataset planned for integration will be prepared for ingestion into the platform by: 

•  Basic curation / profiling / context data according to platform requirements 
•  Mapping and conversion to agreed formats, use of controlled vocabularies 
• 
Incorporation of agreed substance identifiers, controlled vocabularies and 
tagging (e.g. origin) 
Indication of confidentiality of information  

• 
•  Quality control after conversion 
•  Mechanisms for (periodic) ingestion by the platform; updates, versioning 

While  a  significant  part  of  the  preparation  of  IT  solutions  can  be  outsourced,  work  on 
internal data linkages and rules supporting integration will rely on internal experts, which 
are  limited  within  the  agencies.  Extensive  resources  are  already  employed  in  current 
IT/data  infrastructures  of  the  agencies.  The  common  data  platform  on  chemicals  is 
however a new infrastructure that in spite of longer term benefits requires investment for 
its development and additional work on existing datasets, and needs some overhead for 
operations.  

Table 7 provides an overview of the estimated resources required for the development of 
the  platform  and  integration  of  the  datasets  identified  in  a  minimum  viable  product66. 

66  

Outlined in the Feasibility study21 and further refined in the Project Initiation Document accompanying 
this  Staff  Working  Document,  the  Minimum  Viable  Product  (MVP)  is  the  planned  initial 
implementation  of  the  common  data  platform  and  comprises  the  operating  IT  infrastructure  that  is 
delivering  initial  functionalities  (e.g.  basic  database  search,  access  to  data,  export)  providing  an 
integrated experience across the initial datasets contained in the platform (minimum viable dataset) and 
initial set of dedicated services (PACT, legal obligations database, repository of reference values etc.) 
with own further functionalities. The minimum viable dataset includes the following datasets, organised 
according to the Union agency responsible for integration:  

74 

 
 
 
 
Detailed resource estimates for agencies were made in the context of the proposal for a 
regulation on the re-attribution of scientific and technical work between EU Agencies and 
can be found in section 9 of the accompanying staff working document.  

Table 7 – Overview of resource estimates for minimum viable product of common data platform  

FTEs 

Operational costs (EUR) 

Activity  

Y1 

Y2 

Y3 

Y4  

Y1 

Y2 

Y3 

Y4 

Common data platform  

21 

21 

21 

IPCHEM 

Information on regulatory 
processes on chemicals 
Repository of limit values  

on 

Information 
the 
obligations  under  Union 
acts on chemicals 
Environmental 
sustainability information  

1 

0 

1 

0 

0 

3 

0 

1 

0 

1 

3 

0 

1 

0 

1 

9 

3 

0 

1 

0 

1 

950  

3 442  

4 077  

1 300  

0  

0  

0  

0  

0  

200  

0  

650  

0  

380  

0  

650  

0  

230  

0  

200  

0  

0  

0 

0  

- 

- 

ECHA REACH (registration data industrial chemicals, incl. chemical safety reports ); ECHA 
CLP  (Classification  and  Labelling  inventory);  ECHA  BPR  (different  datasets  related  to 
biocidal  active  substance  approval  process,  authorised  products  and  product-substance 
combinations);  ECHA  Prior  Informed  Consent  (substances  subject  to  Regulation  (EU) 
649/2012  concerning  the  export  and  import  of  hazardous  chemicals);  ECHA  Persistent 
Organic  Pollutants  (POP);  ECHA  regulatory  processes  information  (present  ECHA 
PACT);  EU  Chemicals  Legislation  Finder  (EUCLEF);  HBLVR  (under  development, 
dataset underpinning repository of reference values) 

EFSA OpenFoodTox (summary of all EFSA  chemical risk assessments including chemical 
identifiers, critical endpoints, toxicological reference values and metadata from EFSA outputs); 
EFSA  Chemical  Monitoring  Data  (pesticides,  veterinary  medicinal  product  residues  and 
contaminants data, measurements in food/feed); EFSA OpenEFSA (EFSA's scientific work, 
processes);  EFSA  EU_PPP  Agency  IUCLID  (plant  protection  products,  IUCLID  dossiers 
submitted by applicants); 

-  EEA  Air  Quality;  EEA  Waterbase  Water  Quality  (nutrients,  organic  matter,  hazardous 
substances and other chemicals in rivers, lakes, groundwater, transitional, coastal and marine 
waters,  including  records  reported  under  the  Water  Framework  Directive  Watch  List  for 
chemicals  in  surface  waters);  EEA  Waterbase  emissions  (emissions  of  nutrients  and 
hazardous substances to water, reported by EEA member countries and cooperating countries, 
including data on yearly riverine input loads to transitional, coastal and marine waters); EEA 
Industrial  emissions  (as  reported  under  E-PRTR  Regulation  and  Industrial  Emissions 
Directive,  from  releases  to  emissions,  permit  information  etc.);  EEA  National  Emission 
reductions Commitments (NEC) Directive emission inventory data (emissions of certain 
air pollutants); 

-  EMA  human  medicinal  products  data  (environmental  risk  assessment  and  non-clinical 
toxicological data); EMA Veterinary medicinal products (environmental risk assessment and 
maximum residue limit (values and MRL assessment data) 

- 

IPCHEM,  presently  managed  by  JRC,  including  a  number  of  chemical  monitoring 
datasets  structured  into  four  modules:  Environmental  monitoring,  Human  Bio-Monitoring, 
Food and Feed, Products and Indoor Air, to be integrated in the platform by joint undertaking 
by JRC, ECHA and EEA; 

75 

 
 
  
 
 
SUM 

23 

26 

26 

14 

950  

4 292 

5 107  

1 730 

Redirection of information flows 

Redirection of information to certain EU agencies could be foreseen for a limited number 
of information flows (see section 4.2.1, Table 4) in accordance with EU agencies’ mandate 
and expertise. Such redirection is expected to have a beneficial impact on the efficiency 
and  effectiveness  of  data  handling  and  data  interpretation  and  as  such  also  a  positive 
impact on the efficiency and effectiveness on chemical safety assessments.  

5.2. Standard data formats 

In order to ensure that chemicals data is interoperable, the only viable and effective option 
that  was  identified  is  imposing  the  use  of  standard  data  formats  and  controlled 
vocabularies for the transfer of data by EU agencies to the common data platform and in 
particular the use of IUCLID for a limited number of specific legislations. The agencies 
would be required to set standard formats and controlled vocabularies for the information 
in  their  mandate  or  expertise  and  to  cooperate  with  other  agencies  setting  formats  and 
vocabularies in  order to  progressively  move towards a maximisation of interoperability 
between different datasets. 

Under this option, there would be no impact on duty holders under the respective individual 
pieces of chemicals legislation, as they would continue to submit information as they are 
doing today. The expectation is that in the longer term the formats and vocabularies set by 
the EU agencies would not only be used for the transfer of data from the agencies to the 
common data platform, but gradually also for the submission of data by the duty holders 
under the individual pieces of legislation.  

The  requirement  for  agencies  to  develop  and  agree  on  standard  formats  and  controlled 
vocabularies implies additional effort required from them compared to today. The resource 
impact  of  this  requirement  is  subsumed  under  the  resource  estimates  for  the  setup  and 
operation of the common data platform, provided in section 5.1. 

The use of standard formats and controlled vocabularies will have a positive impact on the 
interoperability of information, thus increasing the findability of information. In addition, 
information across regulatory dossiers will be easier to compare. An increased findability 
and comparability will in turn reduce administrative burden for risk assessors and have a 
positive  impact  on  the  effectiveness,  efficiency  and  coherence  of  chemical  safety 
assessments.  

5.3. Transparency  and  use  of  chemicals  data  contained  in  the  common  data 

platform 

Dissemination and sharing of chemicals data 

Table 18 in Annex 3 provides an overview of relevant rules relating to transparency and 
confidentiality  under  various  pieces  of  legislation.  Today  there  is  already  a  very  high 
degree  of  transparency  and  dissemination  of  information  under  the  various  pieces  of 

76 

 
 
 
 
chemicals legislation in the scope of this initiative. Strengthening the transparency rules 
even more in the sense of requiring more information to be disseminated will only lead to 
a marginally larger amount of information becoming publicly available. Assuming that 
the general public is not specialised in interpreting chemicals data, any positive impact on 
EU citizens’ trust in the scientific underpinning of chemical safety assessments is therefore 
also expected to be marginal. 

With regard to confidentiality claims, the table in Annex 3 shows that while the General 
Food Law specifies the information that can be claimed confidential (Article 39(2)), it also 
stipulates  that  that  list  of  information  is  without  prejudice  to  any  sectoral  Union  law 
(Article 39(3)). So, already at the level of food legislation there is no real harmonisation 
of provisions related to confidentiality. As such, it can also be questioned to what extent 
the  very  question  of  harmonising  confidentiality  rules  across  the  chemicals  regulatory 
framework is a valid one.  

If it is still considered however to  ‘harmonise’ confidentiality rules, from the table it is 
apparent that the approach to confidentiality claims under different legislations and 
by different Union agencies is different. Harmonisation of rules on confidentiality claims 
along  the  provisions  of  the  General  Food  Law  would  imply  a  significant  additional 
administrative  burden  on  the  ECHA  to  systematically  verify  all  submitted  claims. 
Indeed,  Article  39b  of  the  General  Food  Law  requires  the  EFSA  to  do  a  concrete  and 
individual examination of each confidentiality claim. In contrast, legislation in the mandate 
of the ECHA, such as the REACH Regulation or the Regulation on Biocidal Products refer 
to  information,  the  disclosure  of  which  shall  normally  be  considered  to  undermine  the 
protection of commercial interests. In other words, instead of a systematic verification of 
a confidentiality claim under the General Food Law, under REACH and the Regulation on 
Biocidal  Products  there  is  a  general  assumption  of  what  constitutes  confidential 
information  and  what  not.  As  a  result,  the  ECHA  does  not  systematically  verify  every 
incoming confidentiality claim, but only in cases of clear need (e.g. in case of a request 
made under Regulation (EC) 1049/2001 regarding public access to European Parliament, 
Council and Commission documents or when a request is made by another agency for data 
sharing).  

Harmonising  transparency  and  confidentiality  rules  may  thus  be  expected  to  lead  to  an 
increase in the number of confidentiality claims submitted by duty holders, causing more 
costs  and  burden  for  duty  holders,  as  well  as  a  higher  burden  for  the  agencies  to 
systematically verify such claims.  

Taking  into account  the  above,  the  added value  of disseminating only  marginally  more 
information than is currently the case through the harmonisation of transparency provisions 
may  not  outweigh  the  costs  and  burden  incurred  by  duty  holders  and  agencies  for  the 
submission and assessment of confidentiality claims.  

In  contrast,  while  the  originator  principle  will  not  change  the  amount  of  information 
shared  with  the  general  public,  it  is  also  not  expected  to  lead  to  an  increase  in  the 
submission  of  confidentiality  claims.  The  principle  allows  for  data  sharing  between 
authorities, which is a prerequisite for data use, and as such is considered to  indirectly 
contribute  to  the  efficiency,  effectiveness  and  coherence  of  chemical  safety 
assessments.   

77 

 
 
Use of chemicals data contained in the common data platform 

The  use  of  chemicals  data  contained  in  the  common  data  platform  will  broaden  and 
streamline the evidence base for EU safety assessors and will therefore have a positive 
impact on the effectiveness, efficiency and coherence of chemicals safety assessment and 
thus on the protection of human health and the environment from chemicals as well as EU 
citizens’  trust  in  the  scientific  underpinning  of  EU  decision-making  on  chemicals,  as  a 
broader and more.  

Since re-use will only be enabled for public authorities under strict conditions and not for 
private parties, no impact is expected on the competitiveness of chemicals companies.  

5.4. Addressing the problem that there is no default generation or submission of 

certain types of chemicals data 

The establishment of a data generation mechanism allows the commissioning of studies 
when there are no legal provisions to obtain them. This will contribute to the creation of a 
complete knowledge base necessary for a robust scientific assessment.  

Table 8  re-iterates  the two options  identified for the establishment of a  data generation 
mechanism with an indication of expected impacts.  

Table  8  –  Options  for  the  establishment  of  a  data  generation  mechanism  with 
expected impacts 

Option  1  –  DGM  with  explicit 
governance 
centralised 
and 
procedures 

Option 2 – obligation on ECHA 

Agencies involved 

Scope 

All EU agencies involved in chemicals 
(ECHA,  EEA, 
related 
EFSA, ECHA, EMA, EU-OSHA) 

legislation 

ECHA 

All  EU  chemicals  legislation  in  the 
scope of the overall legislative proposal 

EU  chemicals  legislation  and 
activities  in  ECHA’s  mandate 
and expertise 

Right  of 
Member States 

initiative  for 

Yes 

No 

Administrative burden 

Possibility 
sample from industry 

to 

request 

High  –  complex  and  long  decision-
making  process  with  several  different 
actors  involved  (Member  States,  EU 
agencies, Commission, expert working 
group) 

Low - study initiation at ECHA’s 
own initiative or at the request of 
the Commission 

Yes 

Yes 

•  Operational costs variable in 
first three years, then EUR 5 

Resources required 

•  Multiple  of  the  amount  under 
option  2  if  larger  scope  is  taken 
into account and similar coverage 
of legislations in scope is assumed 
•  A fixed number of FTEs for each 
the 
involved  and 
agency 
Commission without any foresight 
on  which  agencies  would  have  to 

for 

78 

 
 
 
deal  with  a  larger  or  smaller 
number of study requests 

million  annually  as  of  the 
fourth year67 
1  FTE  in  the  first  year, 
thereafter 2 FTEs per year 

• 

Option 1 – DGM with explicit governance and centralised procedures 

This option is expected to have a high effectiveness given its very broad scope (virtually 
any study relating to or supporting chemicals policy or implementation of Union chemicals 
legislation can be requested) and the fact that Member States can also submit study requests 
besides EU agencies and the Commission.  

The  broad  scope  and  high  possible  number  of  initiators  call  for  the  establishment  of 
procedures and an expert group to assign, assess, and prioritise study requests, which may 
have a  negative impact  on the efficiency of this option. Similarly,  the broad scope will 
require a significant amount of resources, in the form of (i) human resources at the agencies 
to support the mechanism and (ii) financial resources to finance the studies. If the approach 
is taken that a good representation is to be had of all chemicals legislation and activities in 
scope  of  the  DGM,  a  considerable  budget  will  be  required  to  allow  for  the  necessary 
studies. 

Option 2 – Obligation on ECHA to commission scientific studies for the performance of 
its mission 

Since under this option an obligation would be conferred only on the ECHA, the scope of 
this option is automatically limited to chemicals legislation and activities in the mandate 
or expertise of the ECHA. This gives the option a medium effectiveness, but also a high 
efficiency  (the  latter  not  only  because  of  the  involvement  of  only  one  agency  and  the 
limited number of legal acts in scope, which requires less elaborate procedures, but also 
because of the fact that Member States cannot submit study requests under this option). 

As regards resource requirements, for (i) human resources, the ECHA would require 1 FTE 
in the first year and 2 FTEs per year thereafter. In addition, ECHA would require EUR 0 
in the first year, EUR 1 million in the second year, EUR 3 million in the third year and 
EUR 5 million annually from the fourth year onwards.   

5.5. Addressing the problem of an insufficient uptake of academic data 

Table 9 reiterates the options identified. 

Table 9 – Options to address the problem of an insufficient uptake of academic data 

Option 

Description of option 

1 

2 

67  

Legal obligation on EU agencies 

Legal obligation on industry duty holders 

Estimated operational costs year 1: EUR 0; year 2: EUR 1 million; year 3: EUR 3 million; year 4 and 
onwards: EUR 5 million. Detailed resource estimates were made in the context of the proposal for a 
regulation  on  the  re-attribution  of  scientific  and  technical  work between  EU  Agencies and  can be 
found in section 9 of the accompanying staff working document. 

79 

 
 
 
3 

Rely on OECD guidance 

Option 1 – Legal obligation on EU agencies 

This option has the disadvantage that by putting the obligation on agencies, the burden of 
proof  is  shifted.  In  addition,  performing  a  search  on  a  chemical  without  any  specific 
regulatory context or problem definition may be challenging or may result in the retrieval 
of many publications, not all of which may prove to be relevant for a specific case at hand, 
thus leading to inefficiencies. 

In addition, such obligation would lead to a significant burden and cost for the agencies. 
As a reference, resource estimations provided by the administrative team for populating 
the EASIS database were in the range of 0.5 – 1 FTEs per year for the entry of 1,000 studies 
in the database (including quality control). Over the last few years about 400-600 relevant 
studies were added to the platform per year. In a stakeholder consultation it was indicated 
by industry that this number could already be reached for one data-rich substance, such as 
glyphosate or titanium dioxide. 

A similarly high resource requirement was indicated in a stakeholder consultation for the 
nomination  of  a  substance  as  a  persistent  organic  pollutant  under  the  Stockholm 
Convention:  for the gathering  of academic studies as well as monitoring grey literature 
(including monitoring reports and other forms of governmental reports and/or databases), 
a Member State stated that 1 man year is required.  

Requiring searches to be carried out on a selection of specific (categories of) chemicals 
instead  of  all  possible  chemicals  would  reduce  the  burden,  but  several  thousands  of 
academic  studies  can  still  be  expected  to  be  resulting  from  such  obligation.  The 
proportionality  of  this  option  would  largely  depend  on  the  extent  of  the  use  of  the 
information for risk management or regulatory purposes. 

Option 2 – Legal obligation on industry duty holders 

In case of the introduction of an obligation horizontally across the chemicals regulatory 
framework (sub-option 1), the impact on industry duty holders would be significant. The 
amount of time spent on a literature search can be expected to be similar to that spent by 
an  EU  agency  per  substance.  The  difference  with  the  first  option  is  that  in  case  of  an 
obligation on  EU agencies  (option  1), the agencies would have to  cover  a multitude of 
chemicals whereas in case of an obligation on industry duty holders (option 2) that number 
would be more limited per duty holder.  

Where  already  existing  requirements  to  consider  academic  data  are  strengthened  by 
requiring the documentation of the search (sub-option 2) the assessment of the impact on 
industry duty holders depends on the baseline taken: (i) if it is assumed that a search is 
already done  today  given that there is  an existing requirement,  a documentation  of that 
search will only have a marginal impact in terms of costs; (ii) if it is assumed that a search 
is  often  not  done  even  though  there  already  is  a  requirement  (i.e.  if  non-compliance  is 
assumed), then the introduction of a documentation requirement could have a significant 

80 

 
 
 
impact as the situation would change from ‘no literature search’ today to ‘literature search 
+ documentation’ under the new provisions.  

No  significant  administrative  burden  is  expected  for  the  EU  agencies  under  either  sub-
option  as  the  additional  information  found  through  the  literature  search  would  likely 
constitute  a  minor  part  compared  to  the  rest  of  the  regulatory  dossier  provided  by  the 
industry. 

Option 3 – Rely on OECD guidance 

Under this policy option, no action is  needed in  the context of the legislative proposal. 
While the adoption of both the guidance document and search guide and a potential OECD 
recommendation will not create any legal obligation, it will independently contribute to an 
improvement in the uptake of academic data. This will therefore be complementary to any 
legal obligations that may be introduced. Adoption of the aforementioned documents will 
also  promote  international  harmonisation  of  assessment  approaches  and  increased 
interoperability  of  workflows  implemented  by  regulatory  bodies  for  the  identification, 
evaluation and reporting of academic data. 

In view of the fact that this option does not consist in a legal obligation, but is guidance 
only, its effectiveness is difficult to predict. 

5.6. Addressing the problem that duty holders may not report all study results 

Bringing together chemicals data and being allowed to use it will increase the knowledge 
base for scientific assessments and opinions, thus improving their robustness. This will in 
turn increase the acceptance by society of conclusions and regulatory decisions. Knowing 
through the notification of studies that all studies have been considered in an assessment 
further strengthens the trust of citizens in regulatory decisions.    

Table 10 re-iterates the options identified.  

 Table 10 – Options to address the problem that duty holders may not report all study results 

Scope 

Option A 

Option B 

Option C 

Subset of the chemicals: 
substances subject to 
REACH registration 

Laboratories co-notify 

Whole chemicals 
sector 

Laboratories co-notify 

Whole chemicals sector 

Laboratories co-notify 

Database set-up 

Dual notification databases 

Food sector notifications to 
EFSA database 

Rest of notifications to new 
ECHA database 

All notifications accessible 
through common data 
platform 

All notifications go to 
existing EFSA 
notification database 

All notifications 
accessible through 
common data platform 

One notification database under 
common data platform (i.e. food 
sector notification moves from EFSA 
to ECHA) 

All notifications accessible through 
common data platform 

Transparency 

Made public when notified 

Pre-defined redaction 
rules and publication 

Pre-defined redaction rules and 
publication when ensuing 

81 

 
 
  
Sanctions 

Standard enforcement 
activities by Member States 

Content 

Substance identity, notifier 
identity, study title, study 
scope, and timing of study 
(same as under 
Transparency Regulation) 

when ensuing 
application/registration 
is considered 
admissible (same as 
Transparency 
Regulation) 

Market access delay 
were relevant (same as 
under Transparency 
Regulation)  

Standard enforcement 
activities by Member 
States for all other 
cases 

Substance 
identity, 
notifier  identity,  study 
title,  study  scope,  and 
timing  of  study  (same 
as  under  Transparency 
Regulation). 

application/registration is considered 
admissible (same as Transparency 
Regulation) 

Market access delay were relevant 
(same as under Transparency 
Regulation)   

Standard enforcement activities by 
Member States for all other cases 

Substance  identity,  notifier  identity, 
study title, study scope and timing of 
study  (same  as  under  Transparency 
Regulation) 

+  information  specific  to  the  type  of 
substance or regulatory process where 
relevant  

Option A 

No major impediments are discerned for the  feasibility of option A. While the scope is 
limited, it is not expected that this necessarily increases the feasibility of the establishment 
of the required IT infrastructure, as it may be assumed that once the IT setup is developed 
it can be used for notification under all pieces of chemicals legislation, regardless how little 
or how many.  

The use of two separate notification databases – the existing one at EFSA for notifications 
under  the  Transparency  Regulation  and  one  at  ECHA  for  the  notification  of  testing  on 
chemicals subject to REACH implies a duplication of effort while use could be made of 
the already existing database. ECHA will need to set up a new database and processes and 
use the new information (cross-check of study notifications) in its processes, while EFSA 
will continue  its activities  as usual. On the other  hand, ECHA is  known to  have ample 
experience in designing and setting up IT systems. Moreover, as ECHA will be responsible 
for setting up and hosting the common data platform and the making available of study 
notification  information  through  it,  there  is  something  to  be  said  for  establishing  the 
database of study notifications (for studies not subject to a notification obligation under 
the Transparency Regulation) at the ECHA. Presumably, the IT system and design used 
by  EFSA  can  be  re-used  at  ECHA,  with  small  adjustments  as  necessary.  Additional 
resources would be required within ECHA to manage both the users (training, helpdesk 
support, analysis of information) and the technical solution. 

Industry duty holders will need to update their internal planning and processes to include 
the notification requirement in their workflows. An adjustment/setup cost may therefore 

82 

 
 
 
 
  
be  expected.  In  addition,  there  will  be  a  labour  cost  for  preparing  and  submitting 
notifications. This will entail a digital form with a limited number of fields to be filled out 
corresponding  to  the  information  required.  It  is  estimated  that  notification  will  take 
between 15 and 30 minutes per study.  

Based on an estimated number of 16 70868 companies in the EU with REACH obligations, 
100 laboratories and a generous 7 person days per company/laboratory to adjust workflows 
and update internal planning and processes, a one-off total setup cost for the entire EU 
is calculated of ca. EUR 26 million. Annual costs of notification are estimated to amount 
to  ca.  EUR  109  000  for  the  entire  EU,  based  on  7  500  estimated  notifications  and  a 
notification time of 30 minutes. Calculations and figures are given in Table 11.   

An  important  indirect  cost  impacting  industry  under  option  A  is  the  potential 
competitiveness impact of the confidentiality parameters when set to “published when 
notification  submitted”.  This  cannot  be  monetised  in  a  robust  way,  but  the  lack  of 
confidentiality might deter research and development investments or spur divestments out 
of the EU which would lead to a lower economic output of the sector.  

The extent of the benefits69 of this option is a function of the scope and compliance rate. 
The scope in option A is limited to chemicals subject to REACH registration, while the 
compliance rate can be assumed to be driven by the deterrent role of sanctions. For this 
option,  it  is  not  possible  to  impose  a  market  access  delay  as  is  the  case  under  the 
Transparency Regulation, as  the REACH registration process  does not  require any pre-
market  approval  or  authorisation,  so  enforcement  and  sanctions  are  expected  to  be 
determined  by  Member  States.  Sanctions  could  for  example  take  the  form  of  financial 
penalties. Since there is no systematic check or evaluation of each REACH registration 
dossier, it is not unrealistic to assume a certain degree of non-compliance, in line with non-
compliance rates for other elements related to REACH implementation. 

68  

69  

These estimations were calculated in the study supporting this initiative. The estimated number of 
companies  in  the  EU  with  REACH  obligations  is  based  on  REACH  registration  statistics.  The 
estimated number of laboratories is based on the assumption that in each Member State, a REACH 
registrant/applicant has on average at least three laboratory options (>=3 x 27 = approx. 100). The 
estimated  number  of  study  notifications  is  based  on  studies  requested  in  REACH  substance 
evaluation (~ 950), studies in new REACH registrations of new substances (~ 3,600), and studies 
in REACH registration updates where the tonnage band is increased (~ 450; for lower tier only, as 
higher tier is covered by testing proposals evaluated by ECHA). This estimation does not take into 
account any upcoming changes in REACH information and/or registration requirements. 

The benefit of all options is a more effective risk assessment system in the chemicals sector, through 
an increased transparency on the planning of studies to support a regulatory process in chemicals 
legislation. As a result, authorities are informed of the existence of relevant studies for regulatory 
processes. 

83 

 
 
 
 
  
Table 11 – Estimated direct costs for EU industry of a notification requirement under option A  

Business operators (Direct Costs) 

Direct costs after 1 year 

One-off 

1. Adjust notification requirements in internal planning and processes 
Total costs = p (fixed adjustment costs) * q (number of duty holders within scope)  
p (fixed adjustment costs) 

  Hourly salary 

  Hours per workday 

  Person days to adjust 

q (# of companies and labs under REACH)  
  Companies commissioning/carrying out studies under the extended 
mechanism 
  Laboratories facing an adjustment cost 

Recurrent 
1. Labour cost of notifying each study 
Total costs = p (labour cost) * q (number of studies notified)  

p (labour cost per notif.) 
  Hourly salary 

  Notification time requirement 

q (# of studies notified under REACH)  
  Studies to notify under the extended mechanism 

  Co-notification factor 

EUR/h 

h/day 

days 

firms 

labs 

EUR/h 

hours 

notifications/year 

ratio 

EUR 25 787 547 

EUR 25 787 547 

EUR 25 678 422 

EUR 25 678 422 

EUR 1 527.80 

29.1 

7.5 

7 

16 808 

16 708 

100 

EUR 109 125 
EUR 109 125 

EUR 14.60 
29.1 

0.5 

7 500 
5 000 

1.5 

Option B 

No major impediments are discerned for the feasibility of option B. While the scope is 
very  broad,  it  is  not  expected  that  this  significantly  decreases  the  feasibility  of  the 
establishment of the required IT infrastructure, as it may be assumed that once the IT setup 
is  developed  it  can  be  used  for  notification  under  all  pieces  of  chemicals  legislation, 
regardless how little or how many, even though the system would have to be able to receive 
and host a larger number of notifications in case of a broader scope. 

Using the existing notification database at EFSA to direct all notifications to is considered 
an efficient approach. There is no need to set up a new IT structure and staff dealing with 
the database and notifications is already available at EFSA. However, the ECHA will need 
to enable the making available of study notification information through the common data 
platform. The increased number of incoming notifications as a result of the establishment 
of a notification requirement for the entire chemicals regulatory framework may require a 
limited number of additional resources at EFSA.  

84 

 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
Industry duty holders will need to update their internal planning and processes to include 
the notification requirement in their workflows. An adjustment/setup cost may therefore 
be  expected.  In  addition,  there  will  be  a  labour  cost  for  preparing  and  submitting 
notifications. This will entail a digital form with a limited number of fields to be filled out 
corresponding  to  the  information  required.  It  is  estimated  that  notification  will  take 
between 15 and 30 minutes per study.  

Based on an estimated number of 23 39170 companies in the EU with REACH obligations, 
200 laboratories and a generous 7 person days per company/laboratory to adjust workflows 
and update internal planning and processes, a one-off total setup cost for the entire EU 
is calculated of ca. EUR 36 million. Annual costs of notification are estimated to amount 
to  ca.  EUR  375 000 for the entire EU, based on  25 800 estimated notifications and a 
notification time of 30 minutes. Calculations and figures are given in Table 12.   

Research  and  development  investments  are  not  expected  to  be  impacted,  nor  are 
divestments out of the EU expected, as dissemination of notification information is only 
done when a corresponding dossier linked to the relevant regulatory process is considered 
admissible. 

The extent of the benefits71 of this option is a function of the scope and compliance rate. 
The  scope  in  option  B  is  very  wide,  covering  all  chemicals  legislation  in  scope  of  the 
legislative  initiative,  while  the  compliance  rate  can  be  assumed  to  be  driven  by  the 
deterrent  role  of  sanctions.  Under  this  option,  a  market  access  delay  as  under  the 
Transparency Regulation is imposed where relevant, while for all other cases, enforcement 
and sanctions are expected to be determined by Member States. Such sanctions could for 
example take the form of financial penalties. Since a market access delay is quite impactful, 
compliance  rates  could  be  considered  to  be  relatively  high.  Yet,  from  a  legal 
implementation  point  of  view,  addressing  the  complexity  of  amending  h  existing 

70  

71  

These estimations were calculated in the study supporting this initiative. The estimated number of 
companies in the EU with REACH obligations is based on REACH registration statistics (option 
A) and on the assumption that 40% more companies concerned than by REACH alone (expansion 
of scope under option B).  

The  estimated  number  of  laboratories  is  based  on  the  assumption  that  in  each  Member  State,  a 
REACH registrant/applicant has on average at least three laboratory options (>= 3 x 27 = approx. 
100). That number was multiplied by two (=200)(expansion of scope). The estimated number of 
study notifications is based on studies requested annually under REACH substance evaluation (~ 
950), studies in new REACH registrations of new substances (~ 3600), and studies in registration 
updates where the tonnage band is increased (~ 450; lower tier only, as higher tier is covered by 
testing proposals evaluated by the ECHA). In addition, the number is based on studies under all 
relevant chemical sector regulations (REACH ~500 + biocides 7 200 + others 5 000). This does not 
take account of upcoming changes in information/registration requirements. 

The benefit of all options is a more effective risk assessment system in the chemicals sector, through 
an increased transparency on the planning of studies to support a regulatory process in chemicals 
legislation. As a result, authorities are informed of the existence of relevant studies for regulatory 
processes. 

85 

 
 
 
regulatory  procedures  and  their  established  timelines  may  be  too  complex  or  simply 
impossible in a standalone Regulation.  

Table 12 – Estimated direct costs for EU industry of a notification requirement under option B 

Business operators (Direct Costs) 

Direct costs after 1 year 

One-off 

1. Adjust notification requirements in internal planning and processes 

Total costs = p (fixed adjustment costs) * q (number of firms within scope)  

p (fixed adjustment costs) 

  Hourly salary 

  Hours per workday 

  Person/days to adjust 

q (# of firms and labs under REACH)  
  Firms  commissioning/carrying  out  studies  under  the  extended 
mechanism 
  Laboratories facing an adjustment cost 

Recurrent 
1. Labour cost of notifying each study 
Total costs = p (labour cost) * q (number of studies notified)  

p (labour cost per notif.) 
  Hourly salary 

  Notification time requirement 

q (# of studies notified under REACH)  
  Studies to notify under the extended mechanism 

  Co-notification factor 

EUR/h 

h/day 

days 

firms 

labs 

EUR/h 

hours 

notifications/year 

ratio 

EUR 36 416 846 

EUR 36 416 846 

EUR 36 041 456 

EUR 36 041 456 

EUR 1 527.80 

29.1 

7.5 

7 

23 591 

23 391 

200 

 EUR     375 390  
 EUR     375 390  

EUR 14.60 
29.1 

0.5 

25 800 
17 200 

1.5 

Option C 

No major impediments are discerned for the feasibility of option C. While the scope is 
very  broad,  it  is  not  expected  that  this  significantly  decreases  the  feasibility  of  the 
establishment of the required IT infrastructure, as it may be assumed that once the IT setup 
is  developed  it  can  be  used  for  notification  under  all  pieces  of  chemicals  legislation, 
regardless how little or how many, even though the system would have to be able to receive 
and host a larger number of notifications in case of a broader scope. 

A single notification database at ECHA will eventually be an efficient approach, but in the 
short term there would be an efficiency loss associated with the setup of a new database at 
ECHA,  the  abolishment  of  the  existing  EFSA  database  and  the  transfer  of  existing 
notifications to the ECHA database.  

Industry duty holders will need to update their internal planning and processes to include 
the notification requirement in their workflows. An adjustment/setup cost may therefore 
be  expected.  In  addition,  there  will  be  a  labour  cost  for  preparing  and  submitting 

86 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
notifications. This will entail a digital form with a limited number of fields to be filled out 
corresponding  to  the  information  required.  It  is  estimated  that  notification  will  take 
between  15  and  30  minutes  per  study  and  possibly  up  to  60  minutes  per  study  for 
specific pieces of legislation where specific information is requested in addition.  

Based on an estimated number of 23 39172 companies in the EU with REACH obligations, 
200 laboratories and a generous 7 person days per company/laboratory to adjust workflows 
and update internal planning and processes, a one-off total setup cost for the entire EU 
is calculated of ca. EUR 36 million. Annual costs of notification are estimated to amount 
to  ca.  EUR  750 000 for the entire EU, based on 25 800 estimated notifications and a 
notification time of 60 minutes. Calculations and figures are given in Table 13.   

Research  and  development  investments  are  not  expected  to  be  impacted,  nor  are 
divestments out of the EU expected, as dissemination of notification information is only 
done when a corresponding dossier linked to the relevant regulatory process is considered 
admissible. 

The extent of the benefits73 of this option is a function of the scope and compliance rate. 
The  scope  in  option  C  is  very  wide,  covering  all  chemicals  legislation  in  scope  of  the 
legislative initiative, and the compliance rate can be assumed to be driven by the deterrent 
role  of  sanctions.  Under  this  option,  a  market  access  delay  as  under  the  Transparency 
Regulation is imposed where relevant together with additional penalties, while for all other 
cases, enforcement and sanctions are expected to be determined by Member States. Such 
sanctions could for example take the form of financial penalties.  Since a market access 
delay is quite impactful, compliance rates could be considered to be relatively high. Yet, 
from a legal implementation point of view, addressing the complexity of amending existing 
regulatory  procedures  and  their  established  timelines  may  be  too  complex  or  simply 
impossible in a standalone Regulation.  

Table 13 – Estimated direct costs for EU industry of a notification requirement under option C 

Business operators (Direct Costs) 

Direct costs after 1 year 

One-off 

1. Adjust notification requirements in internal planning and processes 
Total costs = p (fixed adjustment costs) * q (number of firms within 
scope)  
p (fixed adjustment costs) 

  Hourly salary 

  Hours per workday 

EUR 36 792 236 

EUR 36 792 236 

EUR 36 041 456 

EUR 36 041 456 

EUR/h 

h/day 

EUR 1 527.80 

29.1 

7.5 

72  
73  

For assumptions and calculations made, see footnote with related explanations for option B 
The benefit of all options is a more effective risk assessment system in the chemicals sector, through 
an increased transparency on the planning of studies to support a regulatory process in chemicals. 
legislation. As a result, authorities are informed of the existence of relevant studies for regulatory 
processes. 

87 

 
 
  
  
  
  
  
  
 
  Person/days to adjust 

q (# of firms and labs under REACH)  
  Firms  commissioning/carrying  out  studies  under  the  extended 
mechanism 
  Laboratories facing an adjustment cost 

days 

firms 

labs 

Recurrent 

1. Labour cost of notifying each study 
Total costs = p (labour cost) * q (number of studies notified)  

p (labour cost per notif.) 
  Hourly salary 

  Notification time requirement 

q (# of studies notified under REACH)  
  Studies to notify under the extended mechanism 

  Co-notification factor 

EUR/h 

hours 

notifications/year 

ratio 

7 

23 591 

23 391 

200 

 EUR     750 780  

 EUR     750 780  

EUR 29.10 
29.1 

1 

25 800 
17 200 

1.5 

5.7. Addressing the problem that a mechanism is lacking for the identification of 

emerging chemical risks 

Establishment of an EU early warning and action system for emerging chemical risks 

The establishment of an early warning and action system for emerging chemical risks will 
allow to shorten the reaction time between early signals of risks and regulatory measures 
to reduce those rusks, and as such will lead to an improved protection of human health and 
the environment. 

Putting the EEA in the lead on an early warning and action system will provide synergies 
with existing workstreams, as early identification of emerging risks is one of the activities 
of the EEA (e.g. for waste), and with the agency’s work on indicators, including work on 
the  zero-pollution  indicator  framework.  Work  on  an  early  warning  system  can  be 
considered as a natural expansion of the EEA’s work on the framework on indicators for 
chemicals, as several indicators can serve also as early warning signals. In addition,  the 
EEA (and also  the  ECHA) are involved in  the Partnership for the Assessment of Risks 
from Chemicals (PARC) through which they can steer the development of the tools for 
early warning signals. 

The work will require additional resources for EEA. EEA will need as of the first year 1 
FTE per year and an operational budget for the first year of EUR 0, for the second year 
EUR 300 000 and as of the third year and thereafter EUR 150 000 per year. Resources 
needed for other agencies would be minimal: the EFSA already operates the emerging risks 
exchange  network  (EREN),  while  the  ECHA  develops  indicators  for  chemicals  -  the 
existing  allocated  resources  should  cover  also  the  activity  related  to  the  early  warning 
system - and EMA and EU-OSHA would only have to contribute with existing information 
they already hold. 

88 

 
 
  
  
  
  
  
  
  
  
  
 
 
6.  COMPARISON OF OPTIONS AND IDENTIFICATION OF PREFERRED OPTION 

Note: detailed resource estimates for agencies for the various preferred options were 
made in the context of the proposal for a regulation on the re-attribution of scientific 
and technical work between EU Agencies and can be found in the accompanying staff 
working document. 

6.1. Addressing  the  problem  that  chemicals  data  is  scattered  and  some 

information flows are suboptimal 

Establishment of a common data platform on chemicals 

As indicated in section 4.2.1., only one viable option was identified to address the problem 
in an effective and efficient manner. That option is the establishment of a common data 
platform on chemicals. Given the ECHA’s mandate and overall expertise, it is considered 
that the ECHA is the most suitable EU agency to establish such platform. Other relevant 
EU agencies and the Commission  should be part of the platform  steering committee  to 
agree on a governance scheme and rolling implementation plans. 

6.2. Addressing the problem that chemicals data is not always interoperable 

As  indicated  in  section  4.2.2.,  only  one  viable  option  was  identified  to  address  in  an 
effective and efficient manner the problem that chemicals data is not always interoperable. 
That  option  is  establishing  standard  data  formats  and  controlled  vocabularies  and 
making their use obligatory. Given the specificities of some pieces of legislation and the 
fact that different EU agencies have different, specific mandates and expertise, the logical 
approach  is  to  require  the  relevant  EU  agencies  to  develop  such  formats  and 
vocabularies for the chemicals data and legislation in their mandate or expertise. 

6.3. Addressing the problem that chemicals data is not always accessible  

Dissemination and sharing of data 

Two  options  were  identified:  (i)  apply  the  transparency  rules  under  the  Transparency 
Regulation horizontally to all chemicals legislation in the scope of this initiative and (ii) 
apply the originator principle. 

Overall, already today there is a very high degree of transparency and dissemination of 
information under the various pieces of chemicals legislation in the scope of this initiative. 
Strengthening  the  transparency  rules  even  more  will  only  lead  to  a  marginally  larger 
amount of information becoming publicly available. The added value of such additional 
dissemination  may be limited for the general  public, the majority of which may not be 
expected to have an in-depth knowledge and expertise on chemicals data. Moreover, in 
view  of  the  fact  that  some  EU  agencies  do  not  systematically  verify  every  incoming 
confidentiality claim, but only in cases of clear need (e.g. in case of a request made under 
Regulation (EC) 1049/2001 regarding public access to European Parliament, Council and 
Commission documents or when a request is made by another agency for data sharing), 
strengthening transparency rules horizontally may be expected to lead to an increase in the 
number  of  confidentiality  claims  submitted  by  duty  holders,  causing  more  costs  and 
burden  for  those  duty  holders,  as  well  as  a  higher  burden  for  those  agencies  to 

89 

 
 
systematically verify such claims. As a result, it can be expected that the added value of 
disseminating  only  marginally  more  information  than  is  currently  the  case  will  not 
outweigh the costs incurred by duty holders for the submission of confidentiality claims.  

In  contrast,  the  originator  principle  avoids  this  imbalance  between  added  value  and 
incurred costs and is thus more proportionate, while still allowing data sharing between 
public authorities as a first and necessary step towards the re-use of data. Based on this, 
option 2 (apply the originator principle) is considered the preferred option.  

6.4. Addressing the problem that there is no default generation or submission of 

certain types of chemicals data 

Two options were identified: (i) establishing a data generation mechanism with explicit 
governance  and  centralised  submission  and  assessment  procedures  (‘option  1’)  and  (ii) 
conferring an obligation on ECHA to commission scientific studies for the performance of 
its mission (‘option 2’). A qualitative comparison of both options is given in Table 14.  

Table 14 – comparison of options for data generation  

Agencies involved 

Scope 

Option  1  –  DGM  with  explicit 
governance 
centralised 
and 
procedures 

Option 2 – obligation on ECHA 

All EU agencies involved in chemicals 
related 
(ECHA,  EEA, 
EFSA, ECHA, EMA, EU-OSHA) 

legislation 

ECHA 

All Union chemicals legislation in the 
scope of the overall legislative proposal 

Union  chemicals  legislation  and 
activities  in  ECHA’s  mandate 
and expertise 

Right  of 
Member States 

initiative  for 

Yes 

No 

Administrative burden 

Possibility 
sample from industry 

to 

request 

Resources required 

High  –  complex  and  long  decision-
making  process  with  several  different 
actors  involved  (Member  States,  EU 
agencies, Commission, expert working 
group) 

Low - study initiation at ECHA’s 
own initiative or at the request of 
the Commission 

Yes 

Yes 

•  Multiple  of  the  amount  under 
option  2  if  larger  scope  is  taken 
into account and similar coverage 
of legislations in scope is assumed 
•  A fixed number of FTEs for each 
agency 
the 
involved  and 
Commission without any foresight 
on  which  agencies  would  have  to 

for 

•  Operational costs variable in 
first three years, then EUR 5 
million  annually  as  of  the 
fourth year74 
1  FTE  in  the  first  year, 
thereafter 2 FTEs per year 

• 

74  

Estimated operational costs year 1: EUR 0; year 2: EUR 1 million; year 3: EUR 3 million; year 4 and 
onwards: EUR 5 million. Detailed resource estimates were made in the context of the proposal for a 
regulation  on  the  re-attribution  of  scientific  and  technical  work between  EU  Agencies and  can be 
found in section 9 of the accompanying staff working document. 

90 

 
 
 
 
deal  with  a  larger  or  smaller 
number of study requests 

The two options are considerably different mainly in terms of scope, resource requirements 
and  administrative  burden.  Taking  into  account  the  fact  that  data  generation  is  already 
possible for food related chemicals by virtue of Article 32 of the General Food Law, and 
the process of substance evaluation under REACH also allows for the request of additional 
data  generation,  it  appears  reasonable  to  accept  a  more  narrowly  scoped  data 
generation mechanism in return for significantly lower resource requirements  and 
administrative  burden.  Moreover,  in  the  spirit  of  a  coherent  approach  to  the 
implementation  of  chemicals  legislation  and  the  delivery  of  high-quality  chemicals 
assessments, it only seems logical to give the same possibility to ECHA as EFSA already 
has today to conduct scientific studies for the performance of its mission.  

Therefore,  option  2  (conferring  an  obligation  on  ECHA  to  commission  scientific 
studies for the performance of its mission) is the preferred option.  

As  a  specific  side-note,  it  is  considered  that  EUON  as  an  existing  data  generation 
mechanism run presently by ECHA should be using the same data generation mechanism 
with  outputs  construed  as  a  database  within  the  common  data  platform  for  maximum 
efficiency and impact.  

6.5. Addressing the problem of an insufficient uptake of academic data 

Table 15 reiterates the options identified. 

Table 15 – Options to address the problem of an insufficient uptake of academic data 

Option 

Description of option 

1 

2 

3 

Legal obligation on EU agencies 

Legal obligation on industry duty holders 

Rely on OECD guidance 

Options  1  and  2  imply  the  introduction  of  new  or  the  strengthening  of  existing  legal 
obligations,  while  option  3  operates  from  a  non-regulatory  guidance  or  incentivisation 
angle. The first two options can therefore be expected to be more effective than the last 
one.  Yet,  the  third  option  can  be  considered  complementary  to  any  legal  obligation 
adopted.  

When comparing options 1 and 2, option 1 clearly has two main disadvantages, notably (i) 
the fact that the burden of proof is reversed and as such the option goes against one of the 
basic principles assumed under the chemicals regulatory framework, and (ii) it comes with 
a large resource requirement for the agencies subject to the obligation as they would need 
to cover all chemicals in scope. 

Taking into account these considerations, option 2 is the preferred option, while option 
3  is  evidently  supported  in  addition.  Within  option  2,  a  strengthening  of  existing 
requirements through the obligation to provide a documentation of the search carried out 

91 

 
 
 
 
is preferred (sub-option 2), as it will have considerable effectiveness (the documentation 
needs to be included in the regulatory dossier) while costs and burden will be limited as 
the legal requirement to do a literature search already exists. 

Considering  it  unlikely,  however,  that  the  requirement  can  be  caught  in  one  standard 
phrasing in a standalone regulation and apply appropriately to several different pieces of 
legislation with requirements relating to a literature search with specific contexts, actors 
etc.  it  is  believed  to  be  suboptimal  to  address  the  problem  through  the  proposed 
regulation  on  chemicals  data.  It  should  rather  be  covered  through  targeted 
amendments of individual legislative texts.  

6.6. Addressing the problem that duty holders may not report all study results 

A comparative overview of the impacts of the three options identified is given in Table 16.  

Table 16 – comparative overview of the impacts of the three identified options 

Feasibility 

Effectiveness 

Efficiency 

Resource  requirements  of 
EFSA and/or ECHA  

Option A 

High 

Lowest 

Lowest 

Medium 

impact 

Negative 
on 
competitiveness  of  duty 
holders 

High 

Financial  impact  on  duty 
holders 

Medium 

Combined  impact  on  duty 
holders (competitiveness + 
financial) 

Highest 

Option B 

High 

Highest 

Highest 

Medium 

Low 

Medium 

Lowest 

Option C 

High 

Highest 

Medium 

Medium 

Low 

Highest 

Medium 

No major impediments are discerned for the feasibility of any of the identified options. In 
terms  of  legal  implementation,  however,  introducing  a  market  access  delay  sanction  as 
currently laid out for the food sector in Article 32d of Regulation (EU) 2018/1725 in a self-
standing  regulation  for  several  different  regulatory  processes  under  specific  pieces  of 
legislation  with  their  own  procedures  and  timelines  is  considered  far-reaching  and  not 
specific enough to address disparities between the various regulatory processes requiring 
the carrying out of studies under the acts listed in Annex I. . It is considered therefore that, 
Member  States’  defined  penalties  and  measures  implementing  those  penalties  would 
facilitate a more process-specific tailored approach and incentivise compliance with the 
study notification requirement. The agencies responsible for handling respective dossiers 
should, to this end, cooperate with Member State enforcement authorities on exchanging 
information and best practices.  

In terms of effectiveness – determined by the scope (legislations covered) and sanctions – 
option  A  scores  lowest,  as  it  covers  only  studies  on  substances  subject  to  REACH 

92 

 
 
 
 
registration and does not allow for market access delay in case of incompliance. In contrast, 
both options B and C cover studies conducted under all chemicals legislations in scope of 
the legislative initiative and impose a market access delay in case of incompliance where 
possible (i.e. in cases where approval or authorisation is required before a chemical can be 
placed on the market). Option C and B can therefore be considered equally effective, 
and both options are clearly more effective than option A.  

The concrete practicalities of the submission of a notification by a duty holder will be the 
same under the three options; notifications will need to be submitted via an electronic form. 
Differences in efficiency of the notification system are thus determined by the setup of the 
notification database and the related resources required by the relevant agencies. The three 
options score quite similar in this respect with advantages and disadvantages associated 
with all of them, in the short, middle and/or longer term.  

Both  options  B  and  C  ultimately  lead  to  the  deployment  of  one  single  database:  under 
option B all notifications are directed to EFSA’s existing database, while under option C 
all notifications have to be sent to a central database at the ECHA. Option C would thus 
require the transfer of the existing notifications in EFSA’s database to the ECHA. As such, 
option B would need the least additional resources in the short term. While the use of two 
databases in option A (continuation of existing EFSA database and establishment of new 
database at ECHA) appears to be the least efficient in the shorter term, the approach draws 
on advantages that both agencies have to offer: EFSA can continue their practice as usual, 
while ECHA has ample experience with setting up IT systems and is expected to set the 
notification system using own IT building blocks with relative ease and can do so in a way 
which  optimises  the  linking  and  interoperability  of  the  notification  database  with  the 
common data platform.    

Duty holders can be impacted in two ways: (i) all options are associated with financial 
costs related to the preparation and submission of notifications and (ii) depending on the 
dissemination policy, competitiveness may be impacted.  

A one-off cost  relates  to  the update of duty  holders’ internal  planning and processes to 
include  the  notification  requirement  in  their  workflows.  In  addition,  there  are  recurring 
costs associated with the actual notification of studies. The one-off setup cost is the same 
per  company  under  all  three  options.  Yet,  since  option  A  has  a  narrower  scope  and 
therefore affects a smaller number of business operators, the overall one-off cost for EU 
industry is lower in option A than in option B or C. With respect to the recurring costs 
related to  the actual  notifications, under option  A and B the  cost  per notification is  the 
same,  while  under  option  C  that  cost  is  expected  to  be  higher  because  the  information 
requirements for the notification may be more elaborate for specific pieces of legislation. 
At EU level, the total recurring annual cost for all EU duty holders together is lowest under 
option A because of that option’s narrower scope. Option B and C have the same scope, 
but option C requires more information to be notified. 

The dissemination policy may have a significant impact on competitiveness. Under option 
A, notification information is made public upon receipt of the notification,  i.e. before a 
corresponding regulatory dossier is submitted. The availability of such information in an 
early stage may have serious detrimental effects on the competitive position of the business 
operator.  Under  options  B  and  C,  notification  information  is  only  disseminated  if  a 

93 

 
 
corresponding valid regulatory dossier has been submitted, thus avoiding any damage to 
competitiveness. 

Combining both elements – financial impacts and impact on competitiveness – option B 
has  the  least  negative  impact  on  duty  holders,  with  option  C  performing  only 
marginally less well and option A having the worst impact on duty holders, mainly 
due the damaging effects on competitiveness.  

Considering all elements described above, a modified option B - taking into account the 
legal implementation challenges relating to the market access delay sanction - as specified 
below, is the preferred option. 

Option B 

Scope 

Whole chemicals sector 

Laboratories co-notify 

Database set-up 

Notifications pursuant to Article 32b of the Transparency Regulation continue to 
go to existing EFSA notification database 

All other notifications go to ECHA notification database 

All notifications accessible through common data platform 

Transparency 

Pre-defined redaction rules and publication when ensuing application/registration 
is considered admissible (same as Transparency Regulation) 

Sanctions 

Content 

Standard enforcement activities by Member States  

Substance  identity,  notifier  identity,  study  title,  study  scope,  and  timing  of  study 
(same as under Transparency Regulation). 

6.7. Addressing the problem that a mechanism is lacking for the identification of 

emerging chemical risks 

Establishment of an EU early warning and action system for emerging chemical risks 

As  indicated  in  section  4.2.7.,  the  only  viable  and  effective  option  identified  is  the 
establishment of an EU early warning and action system, serving as an EU umbrella system 
based  on  inputs  from  EU  agencies,  national  early  warning  systems,  national  and  EU 
initiatives and the scientific community to enable a timely implementation of risk reduction 
measures for the protection of human health and the environment. 

94 

 
 
 
 
ANNEX 1: PROCEDURAL INFORMATION 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

The initiative on chemicals data is under the responsibility of DG Environment (ENV). It 
is  included  in  Decide  planning  with  reference  PLAN/2022/47975  and  mentioned  in  the 
Commission work programme 2023 as one of the follow-up actions on the zero-pollution 
action plan. 

2.  ORGANISATION AND TIMING 

The  initiative  on  chemicals  data  was  first  announced  in  the  Chemicals  Strategy  for 
Sustainability published in October 2020. A call for evidence76 was published on 19 July 
2022. To support the development of the legal proposal, a supporting study was launched 
on 16 May 2022 with a duration of one year and specific input was requested from the 
ECHA, EEA, EFSA, EMA, EU-OSHA and JRC.  

An Inter-Service Steering Group (ISG) on One Substance, One Assessment was set up to 
which  the  following  10  services  participated:  BUDG,  CNECT,  EMPL,  ENV,  GROW, 
JRC, JUST, RTD, SANTE, SG. In addition, ECHA, EEA, EFSA, EMA and EU-OSHA 
were invited and participated as observers.  

The  ISG  met  7  times  in  total,  on  11  February  2021,  13  April  2021,  28  June  2021,  16 
November 2021, 18 February 2022, 27 February 2023 and 9 March 2023. 

In addition to the ISG meetings, interested services and agencies were involved in bilateral 
meetings and discussions on topics that were specifically in their remit or expertise.  

3.  EVIDENCE, SOURCES AND QUALITY 

The  evidence  collected  for  this  staff  working  document  is  based  on  a  several  sources, 
which can be summarised as follows: 

-  Fitness check of the most relevant chemical legislation (excluding REACH)77 
-  Supporting  study  on  streamlining  chemicals  data  flows,  increasing  data 
interoperability, dissemination, re-use and the use of all available data, and on the 
establishment of a data generation mechanism for the purpose of safety assessments 
in the context of the European chemicals regulatory framework 

-  Feasibility study on a common open platform on chemical safety data78 

75  
76  
77  
78  

Decide (europa.eu) 
Chemical safety – better access to chemicals data for safety assessments (europa.eu).  
Fitness Check of the most relevant chemical legislation (excluding REACH) (europa.eu) 
Feasibility study on a common open platform on chemical safety data - Publications Office of the 
EU (europa.eu) 

95 

 
 
  
 
-  Study on a pilot of an EU early warning system for emerging chemical risks to the 

environment79 

-  A comprehensive stakeholder consultation (see also Annex II) 
-  Ad-hoc support from CNECT, JRC, ECHA, EEA, EFSA, EMA  

79  

Pilot of an EU early warning system for emerging chemical risks to the environment.  

96 

 
 
 
 
 
 
 
 
ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) 

A call for evidence for this initiative was published on the Commission website ‘Have your 
say’80 on 19 July 2022. The public and stakeholders were invited to provide feedback on 
this initiative before 16 August 2022. In total, 68 submissions were received from business 
associations (35%), NGOs (16%), individual companies (15%), EU citizens (12%), public 
authorities (9%), others (4%), non-EU citizens (3%), academic/research institutions (3%), 
and trade unions (3%).  

An  extensive  discussion  was  held  with  representatives  of  Member  States  and  Union 
agencies at three meetings of the Expert Group on One Substance, One Assessment81 held 
on 29 September 2021, 2-3 June 2022 and 30 March 2023, respectively. 

Stakeholders  were  informed  and  consulted  during  the  Information  Session  on  One 
Substance,  One  Assessment  with  Stakeholders  held  on  1  June  2022.  Around  800 
participants followed this on-line event.   

In the context  of the  supporting  study  a combination of tools and methods was used to 
gather views and data from different stakeholder groups:  

•  An online questionnaire targeting Member States yielded 15 responses  
•  An online questionnaire targeting academia, industry and NGOs yielded 65 
responses  
•  14 interviews were conducted with Commission services and EU agencies  
three  online  workshops  were  organised  targeting  all  stakeholders  on  15 
• 
November  2022,  19  January  2023  and  27  February  2023,  respectively,  and 
were attended by 44, 72 and 61 participants, respectively  

In table 17 an overview is provided of the main objectives of the different consultation 
tools and the type and number of stakeholders contacted or consulted. For each problem 
or topic, a summary of the results is provided further below.  

Table 17 – Overview of consultation tools 

Tool  

Objective  

Targeted stakeholders  

Stakeholders 
contacted  

Stakeholders 
responded/participated  

Call for evidence 

Online 
questionnaire for 
Member States  
Online 
questionnaire for 
other stakeholders  

Collect data and information 
on the initiative at large 
Collect data and information 
from Member States on the 
initiative at large  
Collect data and information 
from stakeholders on the 
initiative at large 

Interviews  

Obtain rich data and 
information on specific 

All stakeholders, 
including EU citizens 

27 Member States, 
Norway  

Academia, industry, 
industry and business 
associations, NGOs  
European Commission 
services and agencies 
(also an industry 

N/A 

76  

707  

22   

68 

15   

65   

14  

80  
81  

Chemical safety – better access to chemicals data for safety assessments (europa.eu).  
Register of Commission expert groups and other similar entities (europa.eu) 

97 

 
 
 
   
 
 
 
topics in the scope of the 
initiative 

Targeted online 
workshops  

Facilitate discussion on 
possible policy options 
among key stakeholders.  

Final online 
workshop  

Present the findings from 
the second interim report of 
the study supporting the 
initiative and allow for its 
validation by stakeholders, 
such as authorities, NGOs 
and industry stakeholders.  

association and PARC 
coordinators)  
Academia, industry, 
industry and business 
associations, NGOs, 
European Commission 
services, Member States  

Academia, industry, 
industry and business 
associations, NGOs, 
European Commission 
services, Member States 

115 (first online 
workshop)  
166 (second 
online workshop)  

44 (first workshop)  
71 (second workshop) 

224  

62  

Feedback on the establishment of a common data platform on chemicals  
Generally, there was a large support for the establishment of a common data platform on 
chemicals.  Several  public  authorities  stated  that  national  authorities  and  EU  agencies 
should  make  more  data  available  and  claimed  that  public  authorities  should  have 
unrestricted  access  to  all  data  in  the  platform.  Industry  emphasised  the  importance  of 
maintaining the confidentiality of information upon sharing and re-use. NGOs advocated 
for  full  transparency  of  chemicals  data  for  the  general  public.  Some  NGOs  stated  that 
obstacles related to intellectual property rights and confidentiality should be removed to 
allow a broader access to and re-use of information.   

Feedback on options related to data formats   
Several  business  associations  emphasised  that  data  formats  should  be  developed  in 
consultation with stakeholders and take account of existing initiatives. Academics mainly 
raised  the  point  that  it  would  be  essential  for  them  to  have  all  data  available  for  bulk 
download  in  a  common  format  without  the  need  for  any  specific  new  software.  They 
highlighted the importance to report values for a given parameter in a consistent manner 
and in a constant unit. Several Member States reported that they support the principle to 
use the same data formats and tools across different pieces of legislation and across data 
holders as much as possible. Yet, the use of standard data formats should not increase the 
burden on industry or delay regulatory processes. One Member State found coordination 
with the OECD essential. Use should be made of OHTs (OECD harmonised templates). 
Another  Member  State  proposed  to  move  from  human  readable  to  FAIR  and  highly 
granular data, so it can be rendered and or aggregated in a human readable way.   

Feedback on controlled vocabularies  
The majority of the feedback received related to examples where different definitions of 
the  same  concept  were  identified  among  different  legislations.  EU  agencies  commonly 
agreed  on  the  benefit  of  a  controlled  vocabulary.  Industry  associations  indicated  that 
controlled vocabularies should be developed in consultation with stakeholders and should 
take  account  of  existing  initiatives.  With  regard  to  substance  identity,  EU  agencies, 
industry and Member States agreed that it is not possible to harmonise substance identity 
itself. EU agencies raised the idea to work towards a common set of identifiers, which can 
be used for all chemicals data sets. Sector-specific identifiers could be used in addition. 
Data sets should also be linked to the regulatory context in which they were generated, so 
that regulators are aware of the substance definition considered. Several Member States 

98 

 
 
 
 
  
indicated that besides substance identity,  information on the purity of  a substance is of 
similar  importance.  Common  definitions  for  ‘substance’,  ‘constituent’,  ‘component’, 
‘impurity’, ‘substance identity’, ‘intrinsic property’ were considered necessary to ensure 
interoperability  of  different  datasets  generated  under  different  regulatory  frameworks. 
Also, they strongly recommended the involvement of OECD.   

Feedback on transparency and use of data 
Academics indicated that disseminating more than what is already the case today may not 
be necessary for the general public, yet they did consider it necessary for scientific experts 
from academia to have access to more data in order to ensure that the public is protected 
sufficiently  from  any  harms  of  chemicals.  They  noted  that  currently,  their  main  legal 
obstacles to accessing information are confidential business information and the lack of 
access to full industry study reports. They supported harmonisation of transparency rules 
across the chemicals regulatory framework. NGOs called for better data access to enable 
them  to  perform  analyses  and  find  potentially  harmful  and  under-regulated  substances. 
They suggested limiting confidentiality claims to a minimum and applying fees to prevent 
default claims.   

One  NGO  highlighted  that  the  system  that  eventually  will  be  set  up  must  enable 
independent  scientists  to  scrutinize  industry  studies,  to  ensure  that  adverse  effects  or 
indicators of adverse effects are not being overlooked. Today, only study summaries are 
available and in cases of controversies it is of public interest and important to enable access 
to  raw  data  for  independent  parties  on  a  confidential  basis. Industry  representatives 
welcomed the dissemination of assessment reports but highlighted the danger of disclosing 
proprietary and confidential business information that could endanger competitiveness and 
innovation. They suggested limiting transparency to chemicals already on the market and 
ensuring fair sharing of costs involved in the generation of test data. One industry sector 
that  undifferentiated  dissemination  of  data  could  facilitate 
expressed  concerns 
counterfeiting  and  pose  a  risk  to  human  health. Industry  also  suggested  to  work  with  a 
disclaimer  prior  to  providing  access  to  data  in  order  to  clarify  the  legal  situation  and 
ownership  in  order  to  protect  against  misuse.  One  company  expressed  support  for  the 
originator principle.   

With regard to the use of chemicals data, some data providers expressed concern about 
how their data will be interpreted or used. While industry generally accepted data use for 
legal  purposes  by  authorities,  they  highlighted  the  obstacles  of  fair  cost  sharing 
mechanisms,  unfair  competition,  inappropriate  use  of  data,  and  compromised  data 
generation and sharing. A certain risk was perceived of inappropriate use of data as tests 
are  designed  for  specific  purposes  and  specific  chemicals. One  industry  association 
welcomed  the  idea  that  data  use  should  not  support  filling  of  data  gaps  in  regulatory 
dossiers.  

Stakeholder feedback on the establishment of a data generation mechanism  
Divergent  opinions  were  raised  by  several  Member  States,  business  associations, 
companies,  NGOs,  and  one  university  on  the  scope  of  a  data  generation  mechanism, 
ranging  from  ‘only  in  exceptional  cases’,  ‘solving  doubts  or  unclarities  in  specific 
dossiers’,  ‘targeted  and  specific  data  requests’,  to  ‘broad  scope’  and  ‘all  testing  of 
chemicals’.  The  university,  several  business  associations  and  an  individual  expert  also 

99 

 
 
  
  
  
  
emphasised  the  need  to  avoid  overlap  with  existing  systems.  Existing  data  should  be 
evaluated  before  new  data  are  generated.  One  Union  agency  and  a  Member  State  also 
mentioned that data generation should be relevant for several Member States. One Union 
agency, one university and a Member State also stressed the importance of conformity with 
existing principles and obligations, such as the precautionary principle, the polluter pays 
principle or specific obligations for companies (such as to monitor the real-life fate and 
effects of their substances).   

 Several  Member  States  and  business  associations  indicated  that  a  data  generation 
mechanism  should  not  be  used  to  fill  data  gaps  in  dossiers  or  bypass  difficulties  in 
regulatory processes where the data request is in the scope of such processes. An NGO 
pointed out that a data generation mechanism could exclude data on substances covered in 
existing  chemicals  and chemical  product  regulations, and instead focus on low tonnage 
substances  and  substances  with  reduced  information  requirements  under  the  REACH 
Regulation.  On  the  other  hand,  a  Member  State  mentioned  that  a  data  generation 
mechanism could be used to identify new chemicals for monitoring and to assess future 
regulatory needs. Another Member State pointed out that provisions should be foreseen to 
conduct vertebrate animal tests as a last resort only.    

Several Member States indicated that all actors involved in regulatory safety assessments 
should be allowed to make study requests under a data generation mechanism. Academics 
claimed  that  it  should  also  be  possible  for  academia  to  submit  study  requests.Some 
Member  States  and  a  research  consortium  stressed  the  need  for  the  generation  of 
(bio)monitoring data.   

Comments from a Member State, several business associations, and a university on the 
budget included the need for due reflection on the polluter pays principle, as well as the 
fact that it would be difficult to fund the data generation mechanism through industry fees, 
as it would be difficult to allocate them fairly.    

Feedback on the establishment of a requirement to notify studies commissioned or carried 
out by business operators  
Largely, respondents agreed that a study notification requirement would limit to a great 
extent the possibility to hide study results for the regulatory processes that the obligation 
would  apply  to.  Industry  stakeholders  where  generally  against  the  extension  of  the 
notification mechanism while NGO and academia respondents were generally in favour.    

Industry  stakeholders  moreover  underlined  the  compliance  costs  implications  and 
highlighted  the  need  for  proportionate  action. Some  Member  States  and  EU  agencies 
reported  that  a  notification  requirement  would  bring  several  indirect  benefits  related  to 
information  on  progress  throughout  the  regulatory  process  (decisions  taken  by  the 
applicant, planning of future workload). Several business associations expressed concern 
about a notification requirement increasing administrative burden. In addition, they stated 
that  notifications  should  ensure  confidentiality  and  protect  research  and  development 
activities.  A  few  business  associations  stated  that  the  notifications  can  hinder 
competitiveness because only laboratories located in the European Union would be obliged 
to co-notify.  

100 

 
 
  
  
  
  
  
  
ANNEX 3: TRANSPARENCY AND CONFIDENTIALITY RULES 

Table 18 presents an overview of transparency and confidentiality related provisions under different legislations. Underlined text in bold is in particular 
relevant for the assessment made in section 5.3. 

Table 18 - Overview of transparency and confidentiality related provisions under different legislations 
Transparency/dissemination 
Legislation 

Confidentiality 

Regulation 
(EC) No 
178/2002 
laying down 
the general 
principles 
and 
requirement
s of food law, 
establishing 
the 
European 
Food Safety 
Authority 
and laying 
down 
procedures 
in matters of 
food safety 
(General 
Food Law) 
and 
Regulation 
(EU) 
2019/1381 on 
the 

Article 38 
Transparency 

Article 39 
Confidentiality 

1.  The  Authority  shall  carry  out  its  activities  with  a  high  level  of 
transparency. It shall in particular make public:  
(a) agendas, participant lists and minutes of the Management Board, the 
Advisory Forum, the Scientific Committee and the Scientific Panels and 
their working groups;  
(b)  all  its  scientific  outputs,  including  the  opinions  of  the  Scientific 
Committee  and  the  Scientific  Panels  after  adoption,  minority  opinions 
and  results  of  consultations  performed  during  the  risk  assessment 
process always being included;  
(c) scientific data, studies and other information supporting applications, 
including supplementary information supplied by applicants, as well as 
other  scientific  data  and  information  supporting  requests  from  the 
European  Parliament,  the  Commission  and  the  Member  States  for  a 
scientific output, including a scientific opinion, taking into account the 
protection  of  confidential  information  and  the  protection  of  personal 
data in accordance with Articles 39 to 39e; 
(d)  the  information  on  which  its  scientific  outputs,  including  scientific 
opinions  are  based,  taking  into  account  the  protection  of  confidential 
information  and  the  protection  of  personal  data  in  accordance  with 
Articles 39 to 39e;  

1. By way of derogation from Article 38, the Authority shall not make public any 
information  for  which  confidential  treatment  has  been  requested  under  the 
conditions laid down in this Article.  

2.  Upon  the  request  of  an  applicant,  the  Authority  may  grant  confidential 
treatment  only  with  respect  to  the  following  items  of  information  where  the 
disclosure of such information is demonstrated by the applicant to potentially harm 
its interests to a significant degree:  
(a) the manufacturing or production process, including the method and innovative 
aspects thereof, as well as other technical and industrial specifications inherent to 
that process or method, except for information which is relevant to the assessment 
of safety; 
(b)  commercial  links  between  a  producer  or  importer  and  the  applicant  or  the 
authorisation holder, where applicable;  

(c)  commercial  information  revealing  sourcing,  market  shares  or  business 
strategy of the applicant; and  
(d)  quantitative  composition  of  the  subject  matter  of  the  request,  except  for 
information which is relevant to the assessment of safety. 

101 

 
 
 
 
 
 
 
 
 
transparency 
and 
sustainabilit
y of the EU 
risk 
assessment 
in the food 
chain  
(Transparenc
y Regulation) 

(e)  the  annual  declarations  of  interest  made  by  the  members  of  the 
Management  Board,  the  Executive  Director  and  the  members  of  the 
Advisory Forum, the Scientific Committee and the Scientific Panels, as 
well  as  the  members  of  the  working  groups,  and  the  declarations  of 
interest made in relation to items on the agendas of meetings;  
(f) its scientific studies in accordance with Articles 32 and 32d;  
(g) the annual report of its activities;  
(h)  requests  from  the  European  Parliament,  from  the  Commission  or 
from a Member State for scientific opinions which have been refused or 
modified and the justifications for the refusal or modification;  
(i)  a  summary  of  the  advice  provided  to  potential  applicants  at  pre-
submission phase pursuant to Articles 32a and 32c. 

3. The list of information referred to in paragraph 2 shall be without prejudice to 
any sectoral Union law.  

4. Notwithstanding paragraphs 2 and 3:  
(a) where urgent action is essential to protect human health, animal health or the 
environment,  such  as  in  emergency  situations,  the  Authority  may  disclose  the 
information referred to in paragraphs 2 and 3;  
(b)  information  which  forms  part  of  conclusions  of  scientific  outputs,  including 
scientific  opinions,  delivered  by  the  Authority  and  which  relate  to  foreseeable 
effects on human health, animal health or the environment, shall nevertheless be 
made public. 

Information  referred  to  in  the  first  subparagraph  shall  be  made  public 
without delay, with the exception of the information referred to in point 
(c) thereof, as far as applications are concerned, and in point (i) thereof, 
which shall be made public without delay once an application has been 
considered valid or admissible.  

The  information  referred  to  in  the  second  subparagraph  shall  be  made 
public in a dedicated section of the Authority's website. That dedicated 
section shall be publicly available and easily accessible. That information 
shall be available to be downloaded, printed and searched through in an 
electronic format.  

1a. The disclosure of the information referred to in points (c), (d) and (i) 
of the first subparagraph of paragraph 1 to the public shall be without 
prejudice to:  

(a) any existing rules concerning intellectual property rights which set 
out  limitations  on  certain  uses  of  the  disclosed  documents  or  their 
content; and  

Article 39b 
Decision on confidentiality 

1. The Authority shall:  
(a) make public the non-confidential version of the application as submitted by the 
applicant  without  delay  once  that  application  has  been  considered  valid  or 
admissible; 
(b)  proceed,  without  delay,  to  a  concrete  and  individual  examination  of  the 
confidentiality request in accordance with this Article;  
(c) inform the applicant in writing of its intention to disclose information and the 
reasons  for  that,  before  the  Authority  formally  takes  a  decision  on  the 
confidentiality  request.  If  the  applicant  disagrees  with  the  assessment  of  the 
Authority, the applicant may state its views or withdraw its application within two 
weeks of the date on which it was notified of the Authority's position;  
(d) adopt a reasoned decision on the confidentiality request, taking into account 
the  observations  of  the  applicant,  within  10  weeks  of  the  date  of  receipt  of  the 
confidentiality request with respect to applications and without delay in the case of 
supplementary  data  and  information;  notify  the  applicant  of  its  decision  and 
provide  information  on  the  right  to  submit  a  confirmatory  application  in 
accordance with paragraph 2; and inform the Commission and the Member States, 
where appropriate, of its decision; and  

102 

 
 
 
 
 
 
 
 
 
(b) any provisions set out in Union law protecting the investment made 
by innovators in gathering the information and data supporting relevant 
applications for authorisations (‘data exclusivity rules’).  

(e) make public any additional data and information for which the confidentiality 
request  has  not  been  accepted  as  justified  at  the  earliest  two  weeks  after  the 
notification of its decision to the applicant has taken place pursuant to point (d).  

The disclosure to the public of the information referred to in point (c) of 
the  first  subparagraph  of  paragraph  1  shall  not  be  considered  to  be 
explicit  or  implicit  permission  or  licence  for  the  relevant  data  and 
information  and  their  content  to  be  used,  reproduced,  or  otherwise 
exploited in breach of any intellectual property right or data exclusivity 
rules, and the Union shall not be responsible for its use by third parties. 
The Authority shall ensure that clear undertakings or signed statements 
are given to that effect by those who access the relevant information prior 
to its disclosure. 

2. The Management Board shall hold its meetings in public unless, acting 
on  a  proposal  from  the  Executive  Director,  it  decides  otherwise  for 
specific administrative points of its agenda, and may authorise consumer 
representatives or other interested parties to observe the proceedings of 
some of the Authority's activities.  

3.  The  Authority  shall  lay  down  the  practical  arrangements  for 
implementing the transparency rules referred to in paragraphs 1, 1a and 
2 of this Article, taking into account Articles 39 to 39g and 41. 

Article 41 
Access to documents 

1. Notwithstanding the rules on confidentiality provided for in Articles 
39  to  39d  of  this  Regulation,  Regulation  (EC)  No  1049/2001  of  the 
European  Parliament  and  of  the  Council  (1)  shall  apply  to  documents 
held by the Authority. Where environmental information is concerned, 
Regulation (EC) No 1367/2006 of the European Parliament and of the 
Council  (2)  shall  also  apply.  Directive  2003/4/EC  of  the  European 
Parliament  and  of  the  Council  (3)  shall  apply  to  environmental 

Article 39c 
Review of confidentiality 

Before the Authority issues its scientific outputs, including scientific opinions, it 
shall review whether information that has been previously accepted as confidential 
may  nevertheless  be  made  public  in  accordance  with  point  (b)  of  Article  39(4). 
Should  that  be  the  case,  the  Authority  shall  follow  the  procedure  laid  down  in 
Article 39b, which shall apply mutatis mutandis. 

Article 39d 
Obligations with regard to confidentiality 

1. The Authority shall make available, upon request, to the Commission and the 
Member States all information in its possession relating to an application or to a 
request by the European Parliament, by the Commission or by the Member States 
for a scientific output, including a scientific opinion, unless otherwise indicated in 
Union law.  

2. The Commission and the Member States shall take the necessary measures so 
that  information  received  by  them  under  Union  law  for  which  confidential 
treatment  has  been  requested  is  not  made  public  until  a  decision  on  the 
confidentiality request has been taken by the Authority and has become final. The 
Commission and the Member States shall also take the necessary measures so that 
information for which confidential treatment has been accepted by the Authority is 
not made public.  

3. If an applicant withdraws or has withdrawn an application, the Authority, the 
Commission and the Member States shall respect the confidentiality of information 
as granted by the Authority in accordance with Articles 39 to 39e. The application 
shall be considered withdrawn as of the moment the written request to that effect 

103 

 
 
 
 
 
 
 
 
 
 
 
 
 
is received by the competent body that had received the original application. Where 
the  withdrawal  of  the  application  takes  place  before  a  final  decision  on  the 
confidentiality  request  has  been  adopted  by  the  Authority  pursuant  to,  where 
appropriate,  Article  39b(1)  or  (2),  the  Commission,  the  Member  States  and  the 
Authority, shall not make public the information for which confidentiality has been 
requested.  

4.  Members of  the  Management  Board,  the  Executive  Director,  members  of  the 
Scientific Committee and Scientific Panels as well as external experts participating 
in their working groups, members of the Advisory Forum and members of the staff 
of  the  Authority,  even  after  their  duties  have  ceased,  shall  be  subject  to  the 
requirements  of  the  obligation  of  professional  secrecy  pursuant  to  Article  339 
TFEU.  

5. The Authority shall lay down in consultation with the Commission the practical 
arrangements for implementing the confidentiality rules laid down in Articles 39, 
39a,  39b,  39e  and  in  this  Article,  including  arrangements  concerning  the 
submission and treatment of confidentiality requests with respect to information to 
be made public under Article 38, and taking into account Articles 39f and 39g. As 
regards  Article  39b(2),  the  Authority  shall  ensure  that  appropriate  separation  of 
tasks is applied for the assessment of confirmatory applications. 
There is no mention of confidentiality in the legislation. 

information  held  by  Member  States,  notwithstanding  the  rules  on 
confidentiality provided for in Articles 39 to 39d of this Regulation.  

2.  The  Management  Board  shall  adopt  the  practical  arrangements  for 
implementing  Regulation  (EC)  No  1049/2001  and  Articles  6  and  7  of 
Regulation  (EC)  No  1367/2006  by  27  March  2020,  ensuring  as  wide 
access as possible to documents in its possession.  

3. Decisions taken by the Authority pursuant to Article 8 of Regulation 
(EC)  No  1049/2001  may  form  the  subject  of  a  complaint  to  the 
Ombudsman  or  of  an  action  before  the  Court  of  Justice,  under  the 
conditions  laid  down  in  Articles  195  and  230  of  the  EC  Treaty 
respectively. 

Regulations 
related to 
biological 
hazards: 

Regulation 
(EC) No 
1069/2009 of 
laying down 
health rules 
as regards 
animal by-
products and 
derived 

Regulation (EC) 2017/625 
Article 85 
Transparency 

1. Member States shall ensure a high level of transparency on:  
(a) the fees or charges provided for in point (a) of Article 79(1), Article 
79(2) and Article 80, namely on:  
(i) the method and data used to establish these fees or charges;  
(ii)  the  amount  of  the  fees  or  charges,  applied  to  each  category  of 
operators  and  for  each  category  of  official  controls  or  other  official 
activities;  
(iii) the breakdown of the costs, as referred to in Article 81;  

104 

 
 
 
 
 
 
 
 
(b) the identity of the authorities or bodies responsible for the collection 
of the fees or charges.  
2.  Each  competent  authority  shall  make  available  to  the  public  the 
information referred to in paragraph 1 of this Article for each reference 
period and the costs to the competent authority for which a fee or charge 
is due in accordance with point (a) of Article 79(1), Article 79(2) and 
Article 80.  
3.  Member  States  shall  consult  relevant  stakeholders  on  the  general 
methods used to calculate the fees or charges provided for in point (a) of 
Article 79(1), Article 79(2) and Article 80. 

products not 
intended for 
human 
consumption
; 
Regulation 
(EC) No 
852/2004 on 
the hygiene 
of foodstuffs; 
Regulation 
(EC) No 
853/2004  
laying down 
specific 
hygiene rules 
for food of 
animal 
origin; 
Regulation 
(EU) 
2017/625 on 
official 
controls and 
other official 
activities 
performed to 
ensure the 
application 
of food and 
feed law, 
rules on 
animal 
health and 
welfare, 
plant health 

105 

 
 
and plant 
protection 
products  
Regulation 
(EC) No 
1831/2003 on 
additives for 
use in animal 
nutrition 

Article 18 
Transparency and confidentiality 

See Article 18 in second column 

1.  The  Authority  shall  make  public  the  application  for  authorisation, 
relevant  supporting  information  and  any  supplementary  information 
supplied by the applicant, as well as its scientific opinions, in accordance 
with  Articles  38  to  39e  of  Regulation  (EC)  No  178/2002,  which  shall 
apply mutatis mutandis. 

2. In accordance with the conditions and the procedures laid down 
in  Articles  39  to  39e  of  Regulation  (EC)  No  178/2002  and  in  this 
Article, the applicant may submit a request to treat certain parts of 
the  information  submitted  under  this  Regulation  as  confidential, 
accompanied by verifiable justification. The Authority shall assess the 
confidentiality request submitted by the applicant.  

3. In addition to the items of information referred to in Article 39(2) of 
Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the 
Authority may also grant confidential treatment with respect to the 
following  items  of  information,  where  the  disclosure  of  such 
information  is  demonstrated  by  the  applicant  to  potentially  harm  its 
interests to a significant degree:  
(a) the study plan for studies demonstrating the efficacy of a feed additive 
in terms of the aims of its intended use as defined in Article 6(1) of, and 
Annex I to, this Regulation; and  
(b)  specifications  of  the  impurities  of  the  active  substance  and  the 
relevant  methods  of  analysis  developed  internally  by  the  applicant, 
except  for  impurities  that  may  have  adverse  effects  on  animal  health, 
human health, or the environment.  

106 

 
 
 
 
 
 
 
4. This Article is without prejudice to Article 41 of Regulation (EC) No 
178/2002. 

Article 17 
Community Register of Feed Additives 

1.  The  Commission  shall  establish  and  keep  up  to  date  a  Community 
Register of Feed Additives.  

2. The Register shall be made available to the public 

Article 8 
Opinion of the Authority 

1. The Authority shall give an opinion within six months of receipt of a 
valid  application.  This  time  limit  shall  be  extended  whenever  the 
Authority  seeks  supplementary  information  from  the  applicant  under 
paragraph 2. 

6.  The  Authority  shall  make  its  opinion  public,  after  deletion  of  any 
information identified as confidential in accordance with Article 18(2). 

Article 13 
Modification, suspension and revocation of authorisations 

1. On its own initiative or following a request from a Member State or 
from the Commission, the Authority shall issue an opinion on whether 
an authorisation still meets the conditions set out by this Regulation. It 
shall forthwith transmit this opinion to the Commission, to the Member 
States  and,  where  applicable,  to  the  holder  of  the  authorisation.  The 
opinion shall be made public. 
Article 19 
Public Access  

Article 20 
Confidentiality 

107 

 
 
 
 
 
 
 
 
 
 
 
Regulation 
(EC) No 
1935/2004 on 
materials 
and articles 
intended to 
come into 
contact with 
food  

1.  The  Authority  shall  make  public  the  application  for  authorisation, 
relevant  supporting  information  and  any  supplementary  information 
supplied by the applicant, as well as its scientific opinions, in accordance 
with  Articles  38  to  39e  of  Regulation  (EC)  No  178/2002,  which  shall 
apply mutatis mutandis, and with Article 20 of this Regulation. 

2.  Member  States  shall  process  applications  for  access  to  documents 
received under this Regulation in accordance with Article 5 of Regulation 
(EC) No 1049/2001. 

Article 10 
Opinion of the Authority 

1. The Authority shall give an opinion within six months of the receipt 
of a valid application, as to whether, under the intended conditions of use 
of the material or article in which it is used, the substance complies with 
the safety criteria laid down in Article 3 and, where they apply, Article 
4.  

The  Authority  may  extend  the  said  period  by  a  maximum  period  of  a 
further six months. In such a case it shall provide an explanation for the 
delay to the applicant, the Commission and the Member States. 

6.  The  Authority  shall  make  its  opinion  public,  after  deletion  of  any 
information identified as confidential, in accordance with Article 20. 
Article 11 
Transparency 

Where  the  Commission  requests  the  opinion  of  the  Authority  in 
accordance with Article 3(2) of this Regulation, the Authority shall make 
public  without  delay 
the  application  for  authorisation,  relevant 
supporting information and any supplementary information supplied by 
the  applicant,  as  well  as  its  scientific  opinions,  in  accordance  with 

Regulation 
(EC) No 
1331/2008 
establishing 
a common 
authorisatio
n procedure 

1. In accordance with the conditions and the procedures laid down in Articles 
39 to 39e of Regulation (EC) No 178/2002 and in this Article:  
(a)  the  applicant  may  submit  a  request  to  treat  certain  parts  of  the  information 
submitted  under  this  Regulation  as  confidential,  accompanied  by  verifiable 
justification; and 
(b) the Authority shall assess the confidentiality request submitted by the applicant.  

2. In addition to the items of information referred to in Article 39(2) of Regulation 
(EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also 
grant  confidential  treatment  with  respect  to  the  following 
items  of 
information,  where  the  disclosure  of  such  information  is  demonstrated  by  the 
applicant to potentially harm its interests to a significant degree:  
(a) any information provided in detailed descriptions of starting substances and 
mixtures  used  to  manufacture  the  substance  subject  to  the  authorisation,  the 
composition of mixtures, materials or articles in which the applicant intends to use 
that substance, the manufacturing methods of those mixtures, materials or articles, 
impurities, and migration testing results, except for information which is relevant 
to the assessment of safety;  
(b)  the  trademark  under  which  the  substance  shall  be  marketed  as  well  as  the 
tradename  of the mixtures, material or articles in  which it shall be used, where 
applicable; and  
(c) any other information deemed confidential within the specific procedural rules 
referred to in point (n) of Article 5(1) of this Regulation.  

3. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002. 

Article 12 
Confidentiality 

1.  The  applicant  may  submit  a  request  to  treat  certain  parts  of  the  information 
submitted  under  this  Regulation  as  confidential,  accompanied  by  verifiable 
justification, upon submission of the application.  

108 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
for food 
additives, 
food 
enzymes and 
food 
flavourings 

Regulation 
(EC) No 
1829/2003 on 
genetically 
modified 
food and 
feed 

Articles 38 to 39e of Regulation (EC) No 178/2002. The Authority shall 
also make public any request for its opinion as well as any extension of 
period pursuant to Article 6(1) of this Regulation. 

2. Where an opinion by the Authority is required in accordance with Article 3(2) 
of  this  Regulation,  the  Authority  shall  assess  the  confidentiality  request 
submitted by the applicant, in accordance with Articles 39 to 39e of Regulation 
(EC) No 178/2002.  

3. In addition to the items of information referred to in Article 39(2) of Regulation 
(EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also 
grant  confidential  treatment  with  respect  to  the  following  items  of  information, 
where  the  disclosure  of  such  information  is  demonstrated  by  the  applicant  to 
potentially harm its interests to a significant degree:  
(a)  where  applicable,  information  provided  in  detailed  descriptions  of  starting 
substances and starting preparations and on how they are used to manufacture the 
substance subject to the authorisation, and detailed information on the nature and 
composition of the materials or products in which the applicant intends to use the 
substance subject to the authorisation, except for information which is relevant to 
the assessment of safety;  
(b)  where  applicable,  detailed  analytical  information  on  the  variability  and 
stability  of  individual  production  batches  of  the  substance  subject  to  the 
authorisation, except for information which is relevant to the assessment of safety.  

4. Where an opinion by the Authority is not required in accordance with Article 
3(2)  of  this  Regulation,  the  Commission  shall  assess  the  confidentiality  request 
submitted  by  the  applicant.  Articles  39,  39a  and  39d  of  Regulation  (EC)  No 
178/2002 and paragraph 3 of this Article shall apply mutatis mutandis.  

5. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002. 
Article 30 
Confidentiality 

Article 29 
Public access 

1.  The  Authority  shall  make  public  the  application  for  authorisation, 
relevant  supporting  information  and  any  supplementary  information 
supplied by the applicant, as well as its scientific opinions and opinions 
from  the  competent  authorities  referred  to  in  Article  4  of  Directive 

1. In accordance with the conditions and the procedures laid down in Articles 
39 to 39e of Regulation (EC) No 178/2002 and this Article: 
(a)  the  applicant  may  submit  a  request  to  treat  certain  parts  of  the  information 
submitted  under  this  Regulation  as  confidential,  accompanied  by  verifiable 
justification; and  

109 

 
 
 
 
 
 
 
 
 
2001/18/EC, in accordance with Articles 38 to 39e of Regulation (EC) 
No 178/2002 and taking into account Article 30 of this Regulation.  

(b) the Authority shall assess the confidentiality request submitted by the applicant.  

2.  The  Authority  shall  apply  Regulation  (EC)  No  1049/2001  of  the 
European Parliament and of the Council of 30 May 2001 regarding public 
access to European Parliament, Council and Commission documents (1) 
when  handling  applications  for  access  to  documents  held  by  the 
Authority. 

3.  Member  States  shall  handle  applications  for  access  to  documents 
received under this regulation in accordance with Article 5 of Regulation 
(EC) No 1049/2001. 

2. In addition to the items of information referred to in points (a), (b) and (c) of 
Article  39(2)  of  Regulation  (EC)  No  178/2002  and  pursuant  to  Article  39(3) 
thereof,  the  Authority  may  also  grant  confidential  treatment  with  respect  to  the 
following information, where the disclosure of such information is demonstrated 
by the applicant to potentially harm its interests to a significant degree:  
(a)  DNA  sequence  information,  except  for  sequences  used  for  the  purpose  of 
detection, identification and quantification of the transformation event; and  
(b) breeding patterns and strategies.  

Article 28 
Community register 

1. The Commission shall establish and maintain a Community register of 
genetically  modified  food  and  feed,  hereinafter  referred  to  as  ‘the 
Register’.  

3. The use of the detection methods and the reproduction of the reference materials, 
provided under Articles 5(3) and 17(3) for the purpose of applying this Regulation 
to GMOs, food or feed to which an application refers, shall not be restricted by the 
exercise of intellectual property rights or otherwise.  

4. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002. 

2. The Register shall be made available to the public. 

Article 31 
Data protection 

The scientific data and other information in the application dossier required under 
Article 5(3) and (5) and Article 17(3) and (5) may not be used for the benefit of 
another applicant for a period of 10 years from the date of authorisation, unless the 
other  applicant  has  agreed  with  the  authorisation-holder  that  such  data  and 
information may be used.  

On the expiry of this 10-year period, the findings of all or part of the evaluation 
conducted  on  the  basis  of  the  scientific  data  and  information  contained  in  the 
application  dossier  may  be  used  by  the  Authority  for  the  benefit  of  another 
applicant  if  the  applicant  can  demonstrate  that  the  food  or  feed  for  which  it  is 
seeking  authorisation  is  essentially  similar  to  a  food  or  feed  already  authorised 
under this Regulation. 

110 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Regulation 
(EU) 
2015/2283 on 
novel foods 

Article 23 
Transparency and confidentiality 

Article 23 
Transparency and confidentiality 

1.  Where  the  Commission  requests  the  opinion  of  the  Authority  in 
accordance  with  Article  10(3)  and  Article  16  of  this  Regulation,  the 
Authority  shall  make  public  the  application  for  authorisation,  relevant 
supporting information and any supplementary information supplied by 
the  applicant,  as  well  as  its  scientific  opinions,  in  accordance  with 
Articles 38 to 39e of Regulation (EC) No 178/2002 and with this Article.  

1. Where the Commission requests the opinion of the Authority in accordance with 
Article 10(3) and Article 16 of this Regulation, the Authority shall make public the 
application 
information  and  any 
supplementary  information  supplied  by  the  applicant,  as  well  as  its  scientific 
opinions, in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002 
and with this Article.  

relevant  supporting 

for  authorisation, 

2.  The  applicant  may  submit  a  request  to  treat  certain  parts  of  the 
this  Regulation  as  confidential, 
information 
accompanied  by  verifiable  justification,  upon  submission  of  the 
application.  

submitted  under 

2.  The  applicant  may  submit  a  request  to  treat  certain  parts  of  the  information 
submitted  under  this  Regulation  as  confidential,  accompanied  by  verifiable 
justification, upon submission of the application.  

3.  Where  the  Commission  requests  the  opinion  of  the  Authority  in 
accordance  with  Article  10(3)  and  Article  16  of  this  Regulation,  the 
Authority  shall  assess  the  confidentiality  request  submitted  by  the 
applicant in accordance with Articles 39 to 39e of Regulation (EC) No 
178/2002.  

4. In addition to the items of information referred to in Article 39(2) of 
Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the 
Authority  may  also  grant  confidential  treatment  with  respect  to  the 
following items of information, where the disclosure of such information 
is  demonstrated  by  the  applicant  to  potentially  harm  its  interests  to  a 
significant degree:  

(a)  where  applicable,  information  provided  in  detailed  descriptions  of 
starting substances and starting preparations and on how they are used 
to manufacture the novel food subject to the authorisation, and detailed 
information on the nature and composition of the specific foods or food 

3. Where the Commission requests the opinion of the Authority in accordance with 
Article  10(3)  and  Article  16  of  this  Regulation,  the  Authority  shall  assess  the 
confidentiality request submitted by the applicant in accordance with Articles 
39 to 39e of Regulation (EC) No 178/2002.  

4. In addition to the items of information referred to in Article 39(2) of Regulation 
(EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also 
grant  confidential  treatment  with  respect  to  the  following  items  of  information, 
where  the  disclosure  of  such  information  is  demonstrated  by  the  applicant  to 
potentially harm its interests to a significant degree:  
(a)  where  applicable,  information  provided  in  detailed  descriptions  of  starting 
substances and starting preparations and on how they are used to manufacture the 
novel food subject to the authorisation, and detailed information on the nature and 
composition of the specific foods or food categories in which the applicant intends 
to use that novel food, except for information which is relevant to the assessment 
of safety;  
(b)  where  applicable,  detailed  analytical  information  on  the  variability  and 
stability of individual production batches, except for information which is relevant 
to the assessment of safety.  

111 

 
 
  
 
 
 
 
 
 
 
 
 
 
categories in which the applicant intends to use that novel food, except 
for information which is relevant to the assessment of safety;  

(b) where applicable, detailed analytical information on the variability 
and  stability  of  individual  production  batches,  except  for  information 
which is relevant to the assessment of safety.  

5.  Where  the  Commission  does  not  request  the  Authority's  opinion 
pursuant to Articles 10 and 16 of this Regulation, the Commission shall 
assess the confidentiality request submitted by the applicant. Articles 39, 
39a and 39d of Regulation (EC) No 178/2002 and paragraph 4 of this 
Article shall apply mutatis mutandis.  

6. This Article is without prejudice to Article 41 of Regulation (EC) No 
178/2002. 
 There  is  no  mention  of  transparency  or  dissemination  of  data  in  the 
legislation. 

5.  Where  the  Commission  does  not  request  the  Authority's  opinion  pursuant  to 
Articles  10  and  16  of  this  Regulation,  the  Commission  shall  assess  the 
confidentiality  request  submitted  by  the  applicant.  Articles  39,  39a  and  39d  of 
Regulation (EC) No 178/2002 and paragraph 4 of this Article shall apply mutatis 
mutandis.  

6. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002. 

 There is no mention of confidentiality in the legislation. 

Article 10 
Public access to the dossiers 

Article 63  
Confidentiality 

The Authority shall without delay make the dossiers referred to in Article 
8,  including  any  supplementary  information  supplied  by  the  applicant, 
available to the public, with the exception of any information to which 
the rapporteur Member State has granted confidential treatment pursuant 
to Article 63. 

Article 16 
Public access to the information for renewal 

1.  An  applicant  may  submit  a  request  to  treat  certain  parts  of  the  information 
submitted  under  this  Regulation  as  confidential,  accompanied  by  verifiable 
justification.  

2. Confidential treatment may be granted only with  respect to the following 
items of information, where the disclosure of such information is demonstrated by 
the applicant to potentially harm its interests to a significant degree: 
 a) information referred to in Article 39(2) of Regulation (EC) No 178/2002;  

112 

Regulation 
(EC) No 
1924/2006 on 
nutrition and 
health claims 
made on 
foods 

Regulation 
(EC) No 
1107/2009 
concerning 
the placing 
of plant 
protection 
products on 
the market  

 
 
 
 
 
 
 
 
 
 
 
 
 
The Authority shall assess, without delay, any confidentiality request and 
make available to the public the information provided by the applicant 
under  Article  15  as  well  as  any  other  supplementary  information 
submitted by the applicant,  except for information in respect of which 
confidential treatment has been requested and granted by the Authority 
pursuant to Article 63. The Authority, following consultations with the 
Member  States,  shall  lay  down  practical  arrangements  to  ensure  the 
consistency of those assessments. 

(b) the specification of impurity of the active substance and the related methods 
of analysis for impurities in the active substance as manufactured, except for the 
impurities  that  are  considered  to  be  toxicologically,  ecotoxicologically  or 
environmentally relevant and the related methods of analysis for such impurities;  
(c) results of production batches of the active substance including impurities; and 
(d) information on the complete composition of a plant protection product.  

2a. Where the Authority assesses confidentiality requests under this Regulation, the 
conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) 
No 178/2002 and paragraph 2 of this Article shall apply.  

2b. Where Member States assess confidentiality requests under this Regulation, the 
following requirements and procedures apply:  
(a) confidentiality treatment may only be granted with respect to information listed 
in paragraph 2;  
(b)  where  the  Member  State  has  decided  which  information  is  to  be  treated  as 
confidential, it shall inform the applicant of its decision;  
(c)  Member  States,  the  Commission  and  the  Authority  shall  take  the  necessary 
measures so that information for which confidential treatment has been granted is 
not made public;  
(d) Article 39e of Regulation (EC) No 178/2002 shall apply mutatis mutandis;  
(e) notwithstanding paragraph 2 and points (c) and (d) of this paragraph:  
(i) where urgent action is essential to protect human health, animal health or the 
environment, such as in emergency situations, the Member State may disclose the 
information referred to in paragraph 2;  
(ii)  information  which  forms  part  of  the  conclusions  of  the  scientific  outputs 
delivered by the Authority and which relate to foreseeable effects on human health, 
animal health or the environment shall nevertheless be made public. In that case, 
Article 39c of Regulation (EC) No 178/2002 shall apply;  
(f) if the applicant withdraws or has withdrawn an application, Member States, the 
Commission  and  the  Authority  shall  respect  the  confidentiality  as  granted  in 
accordance with this Article. Where the withdrawal of the application takes place 
before  the  Member  State  has  decided  on  the  relevant  confidentiality  request, 

113 

 
 
 
 
 
 
Regulation 
(EC) No 
1907/2006 
concerning 
the 
Registration, 
Evaluation, 
Authorisatio
n and 
Restriction 
of Chemicals 
(REACH), 
establishing 
a European 
Chemicals 
Agency  

Article 209 
Rules on transparency 

To ensure transparency, the Management Board shall, on the basis of a 
proposal  by  the  Executive  Director  and  in  agreement  with  the 
Commission,  adopt  rules  to  ensure  the  availability  to  the  public  of 
regulatory,  scientific  or  technical  information  concerning  the  safety  of 
substances  on  their  own,  in  mixtures  or  in  articles  which  is  not  of  a 
confidential nature. 

Article 118 
Access to information 

1.   Regulation (EC) No 1049/2001 shall apply to documents held by the 
Agency. 

2.   Disclosure of the following information shall normally be deemed to 
undermine the protection of the commercial interests of the  concerned 
person: 
(a) details of the full composition of a mixture; 
(b) without prejudice to Article 7(6) and Article 64(2), the precise use, 
function or application of a substance or mixture, including information 
about its precise use as an intermediate; 

(c)  the  precise  tonnage  of  the  substance  or  mixture  manufactured  or 
placed on the market; 

Member  States,  the  Commission  and  the  Authority  shall  not  make  public  the 
information for which confidentiality has been requested.  

3.  This  Article  is  without  prejudice  to  Directive  2003/4/EC  (1)  and  Regulations 
(EC) No 1049/2001 (2) and (EC) No 1367/2006 (3) of the European Parliament 
and of the Council. 
Article 118 
Access to information 

1.   Regulation (EC) No 1049/2001 shall apply to documents held by the Agency. 

2.      Disclosure  of  the  following  information  shall  normally  be  deemed  to 
undermine the protection of the commercial interests of the concerned person: 
(a) details of the full composition of a mixture; 
(b) without prejudice to Article 7(6) and Article 64(2), the precise use, function or 
application of a substance or mixture, including information about its precise use 
as an intermediate; 
(c) the precise tonnage of the substance or mixture manufactured or placed on the 
market; 
(d) links between a manufacturer or importer and his distributors or downstream 
users. 
Where urgent action is essential to protect human health, safety or the environment, 
such as emergency situations, the Agency may disclose the information referred to 
in this paragraph. 

3.      The  Management  Board  shall  adopt  the  practical  arrangements  for 
implementing  Regulation  (EC)  No  1049/2001,  including  appeals  or  remedies 
necessary for reviewing a partial or full rejection of a confidentiality request, by 1 
June 2008. 

4.   Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 
1049/2001 may form the subject of a complaint to the Ombudsman or of an action 
before the Court of Justice, under the conditions laid down in Articles 195 and 230 
of the Treaty respectively. 

114 

 
 
 
 
 
 
 
 
 
 
 
 
 
(d)  links  between  a  manufacturer  or  importer  and  his  distributors  or 
downstream users. 
Where urgent action is essential to protect human health, safety or the 
environment, such as emergency situations, the Agency may disclose the 
information referred to in this paragraph. 

3.   The Management Board shall adopt the practical arrangements for 
implementing  Regulation  (EC)  No  1049/2001,  including  appeals  or 
remedies  necessary  for  reviewing  a  partial  or  full  rejection  of  a 
confidentiality request, by 1 June 2008. 

4.   Decisions taken by the Agency pursuant to Article 8 of Regulation 
(EC)  No  1049/2001  may  form  the  subject  of  a  complaint  to  the 
Ombudsman  or  of  an  action  before  the  Court  of  Justice,  under  the 
conditions laid down in Articles 195 and 230 of the Treaty respectively. 

Article 119 
Electronic public access 

1.   The following information held by the Agency on substances whether 
on their own, in mixtures or in articles, shall be made publicly available, 
free of charge, over the Internet in accordance with Article 77(2)(e): 
(a) without prejudice to paragraph 2(f) and (g) of this Article, the name 
in the IUPAC nomenclature for substances fulfilling the criteria for any 
of  the  following  hazard  classes  or  categories  set  out  in  Annex  I  to 
Regulation (EC) No 1272/2008: 
— hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 
2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; 

— hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and 
fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 
3.10; 
— hazard class 4.1; 
— hazard class 5.1; 

115 

 
 
 
 
 
 
 
  
(b) if applicable, the name of the substance as given in EINECS; 
(c) the classification and labelling of the substance; 
(d) physicochemical data concerning the substance and on pathways and 
environmental fate; 
(e) the result of each toxicological and ecotoxicological study; 
(f)  any  derived  no-effect 
concentration (PNEC) established in accordance with Annex I; 
(g) the guidance on safe use provided in accordance with Sections 4 and 
5 of Annex VI; 
(h) analytical methods if requested in accordance with Annexes IX or X 
which make it possible to detect a dangerous substance when discharged 
into  the  environment  as  well  as  to  determine  the  direct  exposure  of 
humans. 

level  (DNEL)  or  predicted  no-effect 

2.   The following information on substances whether on their own, in 
mixtures or in articles, shall be made publicly available, free of charge, 
over the Internet in accordance with Article 77(2)(e) except where a party 
submitting  the  information  submits  a  justification  in  accordance  with 
Article  10(a)(xi),  accepted  as  valid  by  the  Agency,  as  to  why  such 
publication  is  potentially  harmful  for  the  commercial  interests  of  the 
registrant or any other party concerned: 

(a) if essential to classification and labelling, the degree of purity of the 
substance  and  the  identity  of  impurities  and/or  additives  which  are 
known to be dangerous; 
(b) the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 
000 tonnes or over 1 000 tonnes) within which a particular substance has 
been registered; 
(c)  the  study  summaries  or  robust  study  summaries  of  the  information 
referred to in paragraph 1(d) and (e); 
(d) information, other than that listed in paragraph 1, contained in the 
safety data sheet; 
(e) the trade name(s) of the substance; 

116 

 
 
 
 
(f) subject to Article 24 of Regulation (EC) No 1272/2008, the name in 
the  IUPAC  nomenclature  for  non-phase-in  substances  referred  to  in 
paragraph 1(a) of this Article for a period of six years; 
(g) subject to Article 24 of Regulation (EC) No 1272/2008, the name in 
the IUPAC nomenclature for substances referred to in paragraph 1(a) of 
this Article that are only used as one or more of the following: 
(i) as an intermediate; 
(ii) in scientific research and development; 
(iii) in product and process orientated research and development. 

Regulation 
(EC) No 
1272/2008 on 
classification
, labelling 
and 
packaging of 
substances 
and 
mixtures,  

Article 42 
The classification and labelling inventory  

Article 24 
Request for use of an alternative chemical name 

1. The Agency shall establish and maintain a classification and labelling 
inventory in the form of a database.  

The information notified pursuant to Article 40(1) shall be included in 
the inventory, as well as information submitted as part of registrations 
under Regulation (EC) No 1907/2006. 

Information  in  the  inventory  which  corresponds  to  the  information 
referred to in Article 119(1) of Regulation (EC) No 1907/2006 shall be 
publicly  accessible.  The  Agency  shall  grant  access  to  the  other 
information  on  each  substance  in  the  inventory  to  the  notifiers  and 
registrants  who  have  submitted  information  on  that  substance  in 
accordance with Article 29(1) of Regulation (EC) No 1907/2006. It shall 
grant access to such information to other parties subject to Article 118 of 
that Regulation. 

2.  The  Agency  shall  update  the  inventory  when  it  receives  updated 
information in accordance with Article 40(2) or Article 41. 3. In addition 
to the information referred to in paragraph 1, the Agency shall, where 
applicable, include the following information in each entry:  

1. The manufacturer, importer or downstream user of a substance in a mixture may 
submit a request to the Agency to use an alternative chemical name which refers to 
that  substance  in  a  mixture  either  by  means  of  a  name  that  identifies  the  most 
important functional chemical groups or by means of an  alternative designation, 
where the substance meets the criteria set out in Part 1 of Annex I  and where he 
can  demonstrate  that  disclosure  on  the  label  or  in  the  safety  data  sheet  of  the 
chemical identity of that substance puts the confidential nature of his business, in 
particular his intellectual property rights, at risk.  

2. Any request referred to in paragraph 1 of this Article shall be made in the format 
referred  to  in  Article  111  of  Regulation  (EC)  No  1907/2006  and  shall  be 
accompanied by a fee.  

The level of the fees shall be determined by the Commission in accordance  with 
the regulatory procedure referred to in Article 54(2) of this Regulation.  

A reduced fee shall be set for SMEs.  

3. The Agency may require further information from the manufacturer, importer or 
downstream  user  making  the  request  if  such  information  is  necessary  to  take  a 
decision. If the Agency raises no objection within six weeks of the request or the 

117 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
(a)  whether,  in  respect  of  the  entry,  there  is  harmonised  classification 
and labelling at Community level by inclusion in Part 3 of Annex VI;  

receipt  of  further  required  information,  the  use  of  the  requested  name  shall  be 
deemed to be allowed.  

(b) whether, in respect of the entry, it is a joint entry between registrants 
of the same substance as referred to in Article 11(1) of Regulation (EC) 
No 1907/2006; 

4. If the Agency does not accept the request, the practical arrangements referred to 
in Article 118(3) of Regulation (EC) No 1907/2006 shall apply.  

(c) whether it is an agreed entry of two or more notifiers or registrants 
in accordance with Article 41;  

5. The Agency shall inform competent authorities of the outcome of the request in 
accordance with paragraph 3 or 4 and provide them with the information submitted 
by the manufacturer, importer or downstream user.  

(d) whether the entry differs from another entry on the inventory for the 
same substance.  

The information referred to in (a) shall be updated where a decision is 
taken in accordance with Article 37(5). 

6. Where new information shows that an alternative chemical name used does not 
provide  sufficient  information  for  necessary  health  and  safety  precautions  to  be 
taken at the workplace and to ensure that risks from handling the mixture can be 
controlled,  the  Agency  shall  review  its  decision  on  the  use  of  that  alternative 
chemical name. The Agency may withdraw its decision or amend it by a decision 
specifying which alternative chemical name is allowed to be used. If the Agency 
withdraws or amends its decision, the practical arrangements referred to in Article 
118(3) of Regulation (EC) No 1907/2006 shall apply. 

7.  Where  the  use  of  an  alternative  chemical  name  has  been  allowed,  but  the 
classification of the substance in a mixture for which the alternative name is used 
no longer meets the criteria set out in section 1.4.1 of Annex I, the supplier of that 
substance  in  a  mixture  shall  use  the  product  identifier  for  the  substance  in 
accordance with Article 18 on the label and in the safety data sheet, and not the 
alternative chemical name.  
8. For substances, whether on their own or in a mixture, where a justification in 
accordance  with  Article  10(a)(xi)  of  Regulation  (EC)  No  1907/2006  regarding 
information  referred  to  in  Article  119(2)(f)  or  (g)  of  that  Regulation  has  been 
accepted as valid by the Agency, the manufacturer, importer or downstream user 
may use on the label and in the safety data sheet a name that will be made publicly 
available  over  the  Internet.  For  those  substances  in  a  mixture  for  which  Article 
119(2)(f) or (g) of that Regulation no longer applies, the manufacturer, importer or 
downstream user may submit a request to the Agency to use an alternative chemical 
name as provided for in paragraph 1 of this Article.  

118 

 
 
 
 
 
 
 
 
 
 
 
9. Where the supplier of a mixture, before 1 June 2015, has demonstrated under 
Article 15 of Directive 1999/45/EC that the disclosure of the chemical identity of 
a substance in a mixture puts the confidential nature of his business at risk, he can 
continue to use the agreed alternative name for the purposes of this Regulation. 

Article 45 
Appointment of bodies responsible for receiving information relating to emergency 
health response 

1.  Member  States  shall  appoint  a  body  or  bodies  responsible  for  receiving 
information  relevant,  in  particular,  for  formulating  preventative  and  curative 
measures, in particular in the event of emergency health response, from importers 
and  downstream  users  placing  mixtures  on  the  market.  This  information  shall 
include the chemical composition of mixtures placed on the market and classified 
as hazardous on the basis of their health or physical effects, including the chemical 
identity  of  substances  in  mixtures  for  which  a  request  for  use  of  an  alternative 
chemical name has been accepted by the Agency, in accordance with Article 24.  

2. The appointed bodies shall provide all requisite guarantees for maintaining the 
confidentiality of the information received. Such information may only be used:  

(a) to meet medical demand by formulating preventative and curative measures, in 
particular in the event of an emergency; 
(b)  where  requested  by  the  Member  State,  to  undertake  statistical  analysis  to 
identify  where  improved  risk  management  measures  may  be  needed.  The 
information shall not be used for other purposes. 

 3. The appointed bodies shall have at their disposal all the information required 
from the importers and downstream users responsible for marketing to  carry out 
the tasks for which they are responsible.  

4.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 53a amending Annex VIII to further harmonise the information relating to 
emergency health response and preventative measures, following consultation with 

119 

 
 
 
 
 
 
 
 
Regulation 
(EU) No 
528/2012 
concerning 
the making 
available on 
the market 
and use of 
biocidal 
products 

Article 67 
Electronic public access 

relevant  stakeholders  such  as  the  European  Association  of  Poison  Centres  and 
Clinical Toxicologists (EAPCCT). 
Article 66 
Confidentiality 

1.      From  the date  on  which the  Commission  adopts  an  implementing 
Regulation providing that an active substance is approved, as referred to 
in point (a) of Article 9(1), the following up-to-date information held by 
the Agency or the Commission on that active substance shall be made 
publicly and easily available free of charge: 

1.   Regulation (EC) No 1049/2001 of the European Parliament and of the Council 
of  30  May  2001  regarding  public  access  to  European  Parliament,  Council  and 
Commission  documents  (  37  )  and  the  rules  of  the  Management  Board  of  the 
Agency,  adopted  in  accordance  with  Article  118(3)  of  Regulation  (EC)  No 
1907/2006, shall apply to documents held by the Agency for the purposes of this 
Regulation. 

(a)  where  available,  the  ISO  name  and  the  name  in  the  International 
Union of Pure and Applied Chemistry (IUPAC) nomenclature; 

(b) if applicable, the name as given in the European Inventory of Existing 
Commercial Chemical Substances; 

(c)  the  classification  and  labelling,  including  whether  the  active 
substance meets any of the criteria set out in Article 5(1); 

(d) physicochemical endpoints and data on pathways and environmental 
fate and behaviour; 

(e) the result of each toxicological and ecotoxicological study; 

2.   The Agency and the competent authorities shall refuse access to information 
where disclosure would undermine the protection of the commercial interests or the 
privacy or safety of the persons concerned. 
Disclosure  of  the  following  information  shall  normally  be  deemed  to 
undermine the protection of the commercial interests or the privacy or safety 
of the persons concerned: 
(a) details of the full composition of a biocidal product; 
(b) the precise tonnage of the active substance or biocidal product manufactured 
or made available on the market; 
(c) links between a manufacturer of an active substance and the person responsible 
for  the  placing  of  a  biocidal  product  on  the  market  or  between  the  person 
responsible for the placing of a biocidal product on the market and the distributors 
of the product; 

(f)  acceptable  exposure  level  or  predicted  no-effect  concentration 
established in accordance with Annex VI; 

(g) the guidance on safe use provided in accordance with Annexes II and 
III; 

(d) names and addresses of persons involved in testing on vertebrates. 
However, where urgent action is essential to protect human health, animal health, 
safety  or  the  environment  or for  other  reasons  of  overriding  public  interest,  the 
Agency or the competent authorities shall disclose the information referred to in 
this paragraph. 

(h) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, 
and Section 4.2 of Title 2 of Annex II. 

3.   Notwithstanding paragraph 2, after the authorisation has been granted, access 
to the following information shall not in any case be refused: 

120 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(a) the name and address of the authorisation holder; 
(b) the name and address of the biocidal product manufacturer; 
(c) the name and address of the active substance manufacturer; 
(d) the content of the active substance or substances in the biocidal product and 
the name of the biocidal product; 
(e) physical and chemical data concerning the biocidal product; 
(f) any methods for rendering the active substance or biocidal product harmless; 
(g) a summary of the results of the tests required pursuant to Article 20 to establish 
the product’s efficacy and effects on humans, animals and the environment and, 
where applicable, its ability to promote resistance; 
(h)  recommended  methods  and  precautions  to  reduce  dangers  from  handling, 
transport and use as well as from fire or other hazards; 
(i) safety data sheets; 
(j) methods of analysis referred to in Article 19(1)(c); 
(k) methods of disposal of the product and of its packaging; 
(l) procedures to be followed and measures to be taken in the case of spillage or 
leakage; 
(m) first aid and medical advice to be given in the case of injury to persons. 

4.   Any person submitting information related to an active substance or a biocidal 
product to the Agency or a competent authority for the purposes of this Regulation 
may request that the information in Article 67(3) and (4) not be made  available, 
including  a  justification  as  to  why  the  disclosure  of  the  information  could  be 
harmful  for  that  person’s  commercial  interests  or  those  of  any  other  party 
concerned. 

2.   From the date on which a biocidal product is authorised, the Agency 
shall make publicly and easily available free of charge the following up-
to-date information: 

(a) the terms and conditions of the authorisation; 

(b) the summary of the biocidal product characteristics; and 

(c) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, 
and Section 5.2 of Title 2 of Annex III. 

3.      From  the date  on  which the  Commission  adopts  an  implementing 
Regulation providing that an active substance is approved, as referred to 
in  point  (a)  of  Article  9(1),  the  Agency  shall,  except  where  the  data 
supplier submits a justification in accordance with Article 66(4) accepted 
as  valid  by  the  competent  authority  or  the  Agency  as  to  why  such 
publication  is  potentially  harmful  for  its  commercial  interests  or  any 
other  party  concerned,  make  publicly  available,  free  of  charge,  the 
following up-to-date information on that active substance: 
(a) if essential to classification and labelling, the degree of purity of the 
substance  and  the  identity  of  impurities  and/or  additives  of  active 
substances which are known to be hazardous; 
(b) the study summaries or robust study summaries of studies submitted 
to support the approval of the active substance; 
(c)  information,  other  than  that  listed  in  paragraph  1  of  this  Article, 
contained in the safety data sheet; 
(d) the trade name(s) of the substance; 
(e) the assessment report. 

4.   From the date on which a biocidal product is authorised, the Agency 
shall, except where the data supplier submits a justification in accordance 
with Article 66(4) accepted as valid by the competent authority or the 
Agency  as  to  why  such  publication  is  potentially  harmful  for  its 

121 

 
 
 
 
 
 
 
 
 
 
  
commercial  interests  or  any  other  party  concerned,  make  publicly 
available, free of charge, the following up-to date information: 
(a) study summaries, or robust study summaries, of studies submitted to 
support the biocidal product authorisation; and 
(b) the assessment report. 

Regulation 
(EU) No 
517/2014 on 
fluorinated 
greenhouse 
gases  

Article 6 
Record keeping 

1.  Operators  of  equipment  which  is  required  to  be  checked  for  leaks 
pursuant  to  Article  4(1),  shall  establish  and  maintain  records  for  each 
piece of such equipment specifying the following information:  

(a) the quantity and type of fluorinated greenhouse gases installed;  

(b)  the  quantities  of  fluorinated  greenhouse  gases  added  during 
installation, maintenance or servicing or due to leakage;  

Article 19 
Reporting  on  production,  import,  export,  feedstock  use  and  destruction  of  the 
substances listed in Annexes I or II 

1.  By  31  March  2015  and  every  year  thereafter,  each  producer,  importer  and 
exporter that produced, imported or exported one metric tonne or 100 tonnes of 
CO2 equivalent or more of fluorinated greenhouse gases and gases listed in Annex 
II  during  the  preceding  calendar  year  shall  report  to  the  Commission  the  data 
specified  in  Annex  VII on  each  of  those  substances  for  that  calendar  year.  This 
paragraph  shall  also  apply  to  undertakings  receiving  quotas  pursuant  to  Article 
18(1).  

(c) whether the quantities of installed fluorinated greenhouse gases have 
been  recycled  or  reclaimed,  including  the  name  and  address  of  the 
recycling or reclamation facility and, where applicable, the certificate 
number;  

2. By 31 March 2015 and every year thereafter, each undertaking that destroyed 1 
metric tonne or 1 000 tonnes of CO2 equivalent or more of fluorinated greenhouse 
gases and gases listed in Annex II during the preceding calendar year shall report 
to the Commission the data specified in Annex VII on each of those substances for 
that calendar year.  

(d) the quantity of fluorinated greenhouse gases recovered;  

(e) the identity of the undertaking which installed, serviced, maintained 
and  where  applicable  repaired  or  decommissioned  the  equipment, 
including, where applicable, the number of its certificate;  

(f) the dates and results of the checks carried out under Article 4(1) to 
(3);  

3. By 31 March 2015 and every year thereafter, each undertaking that used 1 000 
tonnes  of  CO2  equivalent  or more  of fluorinated  greenhouse  gases  as  feedstock 
during  the  preceding  calendar  year  shall  report  to  the  Commission  the  data 
specified in Annex VII on each of those substances for that calendar year.  

4. By 31 March 2015 and every year thereafter, each undertaking that placed 500 
tonnes of CO2 equivalent or more of fluorinated greenhouse gases and gases listed 
in Annex II contained in products or equipment on the market during the preceding 
calendar year shall report to the Commission the data specified in Annex VII on 
each of those substances for that calendar year.  

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(g) if the equipment was decommissioned, the measures taken to recover 
and dispose of the fluorinated greenhouse gases.  

2. Unless the records referred to in paragraph 1 are stored in a database 
set up by the competent authorities of the Member States the following 
rules apply: 

(a)  the  operators  referred  to  in  paragraph  1  shall  keep  the  records 
referred to in that paragraph for at least five years;  

(b)  undertakings  carrying  out  the  activities  referred  to  in  point  (e)  of 
paragraph 1 for operators shall keep copies of the records referred to in 
paragraph 1 for at least five years.  

The  records  referred  to  in  paragraph  1  shall  be  made  available,  on 
request, to the competent authority of the Member State concerned or to 
the Commission. To the extent that such records contain environmental 
information, Directive 2003/4/EC of the European Parliament and of the 
Council  (1)  or  Regulation  (EC)  No  1367/2006  of  the  European 
Parliament and of the Council (2) shall apply as appropriate. 
(Aarhus convention) 

3. For the purpose of Article 11(4), undertakings supplying fluorinated 
greenhouse gases shall establish records of relevant information on the 
purchasers  of  fluorinated  greenhouse  gases  including  the  following 
details:  

(a) the numbers of certificates of the purchasers; and  

(b) the respective quantities of fluorinated greenhouse gases purchased. 
The undertakings supplying fluorinated greenhouse gases shall maintain 
those records for at least five years.  

5. Each importer of  equipment that places on the market pre-charged equipment 
where hydrofluorocarbons contained in this equipment have not been placed on the 
market prior to the charging of the equipment shall submit to the Commission a 
verification document issued pursuant to Article 14(2).  

6.  By  30  June  2015  and  every  year  thereafter,  each  undertaking  which  under 
paragraph 1 reports on the placing on the market 10 000 tonnes of CO2 equivalent 
or  more  of  hydrofluorocarbons  during  the  preceding  calendar  year  shall,  in 
addition, ensure that the accuracy of the data is verified by an independent auditor. 
The auditor shall be either:  
(a) accredited pursuant to Directive 2003/87/EC; or  
(b) accredited to verify financial statements in accordance with the legislation of 
the Member State concerned.  
The  undertaking  shall  keep  the  verification  report  for  at  least  five  years.  The 
verification report shall be made available, on request, to the competent authority 
of the Member State concerned and to the Commission.  

7. The Commission may, by means of implementing acts, determine the format and 
means of submitting the reports referred to in this Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 24.  

8.  The  Commission  shall  take  appropriate  measures  to  protect  the 
confidentiality  of  the  information  submitted  to  it  in  accordance  with  this 
Article. 

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The  undertakings  supplying  fluorinated  greenhouse  gases  shall  make 
such  records  available,  on  request,  to  the  competent  authority  of  the 
Member State concerned or to the  Commission. To the  extent that the 
records  contain  environmental  information,  Directive  2003/4/EC  or 
Regulation (EC) No 1367/2006 shall apply as appropriate.  

4. The Commission may, by means of an implementing act, determine 
the format of the records referred to in paragraphs 1 and 3 of this Article 
and  specify  how  they  should  be  established  and  maintained.  That 
implementing act shall be adopted in accordance with the examination 
procedure referred to in Article 24 

Article 27 
Reporting by undertakings 

1. Each year by 31 March, each undertaking shall communicate to the Commission, 
sending a copy to the competent authority of the Member State concerned, the data 
listed in paragraphs 2 to 6 for each controlled substance and  each new substance 
listed in Annex II for the previous calendar year. 

 2. Each producer shall communicate the following data:  
(a) its total production of each substance referred to in paragraph 1; 
(b) any production placed on the market or used for the producer’s own account 
within  the  Community,  separately  identifying  production  for  feedstock,  process 
agent and other uses;  
(c)  any  production  to  meet  the  essential  laboratory  and  analytical  uses  in  the 
Community, licensed in accordance with Article 10(6);  
(d) any production authorised under Article 10(8) to satisfy essential laboratory 
and analytical uses of Parties;  
(e)  any  increase  in  production  authorised  under  Article  14(2),  (3)  and  (4)  in 
connection with industrial rationalisation;  
(f) any quantity recycled, reclaimed or destroyed and the technology used for the 
destruction, including amounts produced and destroyed as by-product as referred 
to in Article 3(14);  
(g) any stocks;  

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(h) any purchases from and sales to other producers in the Community.  

3. Each importer shall communicate for each substance referred to in paragraph 1 
the following data:  

(a)  any  quantities  released  for  free  circulation  in  the  Community,  separately 
identifying imports for feedstock and process agent uses, for essential laboratory 
and analytical uses licensed in accordance with Article 10(6), for use in quarantine 
and  preshipment  applications  and  for  destruction.  Importers  which  imported 
controlled  substances  for  destruction  shall  also  communicate  the  actual  final 
destination or destinations of each of the substances, providing separately for each 
destination  the  quantity  of  each  of  the  substances  and  the  name  and  address  of 
destruction facility where the substance was delivered;  
(b) any quantities imported under other customs procedures, separately identifying 
the customs procedure and the designated uses;  
(c)  any  quantities  of  used  substances  referred  to  in  paragraph  1  imported  for 
recycling or reclamation;  
(d) any stocks;  
(e) any purchases from and sales to other undertakings in the Community;  
(f) the exporting country.  

4. Each exporter shall communicate for each substances referred to in paragraph 1 
the following data:  
(a)  any  quantities  of  such  substances  exported,  separately  identifying  quantities 
exported to each country of destination and quantities exported for feedstock and 
process agent uses, essential laboratory and analytical uses, critical uses and for 
quarantine and preshipment applications;  
(b) any stocks;  
(c) any purchases from and sales to other undertakings in the Community;  
(d) the country of destination. 

5. Each undertaking destroying controlled substances referred to in paragraph 1 and 
not covered by paragraph 2 shall communicate the following data:  

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(a) any quantities of such substances destroyed, including quantities contained in 
products or equipment;  
(b)  any  stocks  of  such  substances  waiting  to  be  destroyed,  including  quantities 
contained in products or equipment; (c) technology used for the destruction.  

6.  Each  undertaking  using  controlled  substances  as  feedstock  or  process  agents 
shall communicate the following data:  
(a) any quantities of such substances used as feedstock or process agents;  
(b) any stocks of such substances;  
(c) the processes and emissions involved.  

7. Each year before 31 March, each producer or importer which holds a licence 
under Article 10(6) shall, for each substance for which an authorisation has been 
received, report to the Commission, sending a copy to the competent authority of 
the Member State concerned, the nature of the use, the quantities used during the 
previous year, the quantities held in stock, any quantities recycled, reclaimed or 
destroyed,  and  the  quantity  of  products  and  equipment  containing  or  relying  on 
those substances placed on the Community market and/or exported.  

8. The Commission shall take appropriate steps to protect the confidentiality 
of the information submitted to it.  

9. The format of the reports referred to in paragraphs 1 to 7 shall be established in 
accordance with the management procedure referred to in Article 25(2).  

10.  The  Commission  may  amend  the  reporting  requirements  laid  down  in 
paragraphs 1 to 7.  

Those measures, designed to amend non-essential elements of this Regulation, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 25(3). 
Article 49 

126 

Directive 
2009/48/EC 

Article 49 

 
 
 
 
 
 
 
 
 
Transparency and confidentiality  
When the competent authorities of the Member States and the Commission adopt 
measures under this Directive, the requirements of transparency and confidentiality 
provided for in Article 16 of Directive 2001/95/EC shall apply. 

on the safety 
of toys 

Regulation 
(EC) No 
1223/2009 on 
cosmetic 
products 

Transparency and confidentiality  
When  the  competent  authorities  of  the  Member  States  and  the 
Commission  adopt  measures  under  this  Directive,  the  requirements  of 
transparency and confidentiality provided for in Article 16 of Directive 
2001/95/EC shall apply. 
Article 21 
Access to information for the public 
Without prejudice to the protection, in particular, of commercial secrecy 
and  of  intellectual  property  rights,  the  responsible  person  shall  ensure 
that the qualitative and quantitative composition of the cosmetic product 
and,  in  the  case  of  perfume  and  aromatic  compositions,  the  name  and 
code number of the composition and the identity of the supplier, as well 
as  existing  data  on  undesirable  effects  and  serious  undesirable  effects 
resulting from use of the cosmetic product are made easily accessible to 
the public by any appropriate means.  

The  quantitative  information  regarding  composition  of  the  cosmetic 
product  required  to  be  made  publicly  accessible  shall  be  limited  to 
hazardous substances in accordance with Article 3 of Regulation (EC) 
No 1272/2008. 

127